Orthosis, Spinal Pedicle Fixation

XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.

Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

PASS LP, REF numbers:

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050

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.

5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm,

This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).

Gibralt Spine System Polyaxial Screw

The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110

Screw inserters may not mate properly with hex interface of the screws.

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111

Screw inserters may not mate properly with hex interface of the screws.

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113

Screw inserters may not mate properly with hex interface of the screws.

PedFuse Reset Screw; Model: 01-80115-55

During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.

5.0mm Unit Rod 270mm

DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t