The Recall Desk
ModerateFDA (Devices)·Z-0834-2016·Announced 2016-03-02

Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion

Zimmer Biomet is recalling NexGen Knee LPS and Lock femoral components because the LDPE packaging bag adheres to the polished implant surface.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging defect (bag adhesion) without reported injuries or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling NexGen Knee LPS Porous FEM, NexGen Knee LPS Option FEM, and NexGen Knee Lock FEM prostheses. The recall involves 88,389 units of these semi-constrained, cemented knee implants distributed worldwide, including the United States and numerous international markets.

The reason for the recall is that the low-density polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface. This packaging defect may affect the handling or inspection of the device prior to surgical use.

Patients who have already received these implants should contact their healthcare provider for guidance. Healthcare facilities should check their inventory for the specific item and lot numbers listed in the official recall notice to identify affected units.

The recalled product

Product
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due t
Affected units
88,389

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →