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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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 →Related recalls
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Similar recalls
- ModerateZimmer Biomet Recalls NEXGEN LPS-FLEX Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls NEXGEN GSF Porous Femoral LPS Flex Implants
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- ModerateZimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion
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- ModerateZimmer Biomet Recalls LPS-FLEX Knee Implants Due to Packaging Residue
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- ModerateZimmer Biomet Recalls Knee Implants Due to Packaging Residue
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