Synthes (USA) Products Recalls

Hazard: Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Hazard: Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Hazard: Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Hazard: The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.

Hazard: There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.

Hazard: There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.

Hazard: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Hazard: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Hazard: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Hazard: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Hazard: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Hazard: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Hazard: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Hazard: The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.

Hazard: These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03.820.352 lot 5919006 is a 10 mm Strut.

Hazard: There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.

Hazard: The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.

Hazard: Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

Hazard: Non-conforming material used.

Hazard: The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Hazard: The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Hazard: The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Hazard: The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Hazard: The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Hazard: The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Hazard: The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Hazard: The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Hazard: DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

Hazard: DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

Hazard: DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.