Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion Issue
Zimmer Biomet is recalling NexGen Knee femoral prostheses 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, and the hazard is a packaging defect (bag adhesion) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific NexGen Knee femoral prosthesis components, including CR Option, CR Porous, CR Precoat, LPS Porous, and LPS Precoat models. The recall involves 32,508 units distributed nationwide in the United States and internationally to numerous countries.
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 implantation.
Healthcare providers and patients who have received these specific knee implants should contact Zimmer Biomet for further instructions. The affected item numbers and lot numbers are listed in the official recall documentation.
The recalled product
- Product
- NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes This device is indicated for patient
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 32,508
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 →Related recalls
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