Recalls for Thoracolumbosacral Pedicle Screw System

Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Polyaxial screws do not meet performance standards.

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.

Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew

Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.

Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.

During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.

Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.

Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.

Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.

Potential for intraoperative screw head separation at weld location.

the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.

The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications

The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.

Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.

Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.

The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.

Device does not mate as intended.

Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.

Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.

Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.

Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.

The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.

The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.

Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery.

Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.

Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current NewPort MIS System Surgical Technique.

Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use.

Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.

This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.

This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.

The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.

On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.

Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

The tulip portion of the screw assembly can disengage from the shank after implantation.

Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this system. The labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment.

There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.

Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery.

Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.

Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.

Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and material missing. There were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events we

Stryker received four reports regarding a handle which separates at the point where it is welded to the shaft on the Xia 3 Anti-Torque Key during surgery.

Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolongation of OR time.

Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.

Screws are longer then size etched on the screw.

There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.

There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.

One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability.

The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip.

The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws.

The tip of the instrument may fracture during use.

Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.

This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA.

This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA.

Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing. During the same period, there were 15 complaints reported where the tip broke off at the weld after repeated use (1-3 years). The firm found several possible ca

This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product.

Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)

Tip of PathFinder surgical instrument broke during procedure.

Tip of PathFinder surgical instrument broke during procedure.

Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod

Screw may be incorrectly etched as to length.

Screw may be incorrectly etched as to length.

Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.

Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.

Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain.

Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct Java System (IFU reference: 046WAN0000T) and Universal Clamp System (IFU reference: SNA027-N-90001).

Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct Java System (IFU reference: 046WAN0000T) and Universal Clamp System (IFU reference: SNA027-N-90001).

Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)

Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.

The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

Potential for the incorrect screw to be included in the package.

Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.

Potential for the polyaxial screw to become disassembled during implant.

Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.

This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.

6.0x50mm poly-reduction screws were laser etched 6.0x45

Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device

Packages labeled as containing 110mm rods may contain 100mm rods.