Zimmer Recalls NEXGEN Knee Implant Components Due to Packaging Validation Issues
Zimmer is recalling NEXGEN knee implant components because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
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: This is an FDA Class II recall. The hazard is theoretical because the products passed seal integrity testing, but the lack of proper validation constitutes a significant quality control issue that warrants a moderate severity rating.
Plain-English summary
Zimmer, Inc. is recalling specific NEXGEN knee implant components, including tibia plates, taper plugs, pegs, patellae, and stem extensions. The recall affects 7,044,680 units that were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. These products were distributed nationwide in the United States and in numerous international markets, including Canada, the United Kingdom, and various countries in Europe and Asia.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing showed that the packaging trays met the acceptance criteria for sterile barrier integrity with 99% reliability and a 90% confidence interval, Zimmer decided to recall all non-expired lots from this specific facility and operation to ensure patient safety.
Healthcare providers and patients should check their inventory and patient records for the specific catalog numbers listed in the recall notice. If you have received or used these products, contact Zimmer, Inc. or your healthcare provider for further instructions on replacement or evaluation.
The recalled product
- Product
- NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STEMMED TI NEXGEN OPTION STEMMED TIB NEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT, 1 NEXGEN FLU
- Manufacturer
- Zimmer, Inc.
- Affected units
- 7,044,680
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 44 recalled by Zimmer, 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.
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