Zimmer NexGen All-Poly Patella Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella implants due to insufficient sealer calibration data affecting sterility.
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 involves a potential sterility breach due to packaging calibration issues, which is a moderate risk without reported injuries or deaths.
Plain-English summary
Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella implants (Item no. 597206526) used in total knee arthroplasty. The recall involves specific lots of the product, which is distributed nationwide in the United States.
The recall was initiated because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile, and the calibration issue raises concerns regarding the integrity of the sterile packaging.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions on how to handle the affected implants.
The recalled product
- Product
- Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total knee arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. 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 72 products in this recall →Related recalls
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