Zimmer NexGen All-Poly Patella Components Recalled for Calibration Issues
Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella and related knee arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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 source text does not report any injuries, illnesses, or deaths, and the hazard is related to manufacturing calibration data rather than a confirmed high-risk pathogen or structural failure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific NexGen All-Poly Patella, Cemented Stem Extension, Fluted Stem Extension, and Micro All-Poly Pat components used in total knee arthroplasty. The recall affects 53,338 units 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. The source text does not specify reported injuries, illnesses, or deaths associated with this recall.
Healthcare providers and facilities should identify affected units by checking the lot numbers listed in the official recall notice. Consumers who have had these implants should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NE
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 53,338
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.
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