Recalls for Bit, Drill

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.

The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.

The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.

affected parts and lots of the Cannulated Drill Bits have the potential to break during use

Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier.

There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.

Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.

The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.

Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.

Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.

Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.

Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.

Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.

The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use.

The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use.

Synthes is initiating a recall of the Drill Bit for 5.0mm Recon Screws with large Quick Coupling due to the potential for the drill stop to slip on the drill bit.

The epoxy is flaking off the drill bits and countersinks.

Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.

Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.

SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable

Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.

Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)

Products were distributed with the incorrect instructions for use.

Products were distributed with the incorrect instructions for use.

The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.

Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability.

Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the 4.5mm surgical motor using a AO 4.5mm male drive connexion. The countersink bit is coupled to a 1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding.

A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.

A review of complaints identified a trend for drills breaking.