Zimmer Recalls Hip Prostheses Due to Unvalidated Packaging Operations
Zimmer is recalling specific hip prosthesis models 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: The recall is classified as FDA Class II. The source text explicitly states that the products met acceptance criteria for sterile barrier integrity, indicating the hazard is theoretical or precautionary rather than a confirmed failure, which aligns with the 'voluntary precautionary recalls' criterion for a Moderate severity score.
Plain-English summary
Zimmer, Inc. is recalling specific models of hip prostheses, including the Moore Hip Pros Long Fenes, Moore Hip Pros NRW Str Fe, Moore Hip Pros Str Fenest, and Thompson Hip Prosthesis sizes 3, 4, 5, and 6. 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 countries worldwide, including Belgium, Canada, China, France, Germany, India, Japan, and the United Kingdom.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations in Building 1 were not properly validated. To assess the impact, Zimmer conducted seal integrity testing to evaluate if the previously packaged product met established requirements for sterile barrier integrity. The acceptance criteria for this testing required 99% reliability with a 90% confidence interval. The testing showed that the packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays.
Despite the positive test results, Zimmer has decided to recall all manufacturing lots that have not expired and were sterile packaged in the affected facility operations. Consumers and healthcare providers should check their inventory for the specific product codes listed in the official recall notice. If you have these products, contact Zimmer, Inc. for instructions on how to return or replace them.
The recalled product
- Product
- MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
- 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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