Zimmer Recalls Modular Hip Implants Due to Packaging Validation Issues
Zimmer is recalling specific lots of Modular Austin Moore and Moore Hip ProS hip implants because packaging operations at a Puerto Rico facility were not properly validated.
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 involving a sterile barrier integrity concern where the product passed subsequent testing, fitting the criteria for a voluntary precautionary recall with low-risk contamination potential.
Plain-English summary
Zimmer, Inc. is recalling 7,044,680 units of Modular Austin Moore SOLI and Moore Hip ProS REG SOLID hip implants. The recall affects products sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The affected lots were distributed nationwide in the United States and in numerous international markets, including Canada, the United Kingdom, and various countries in Europe, Asia, and the Middle East.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations at the specified facility were not properly validated. Although subsequent seal integrity testing indicated that the packaging trays met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired manufacturing lots from this specific operation to ensure safety.
Consumers and healthcare providers should check the lot numbers of their hip implants against the list provided in the official recall notice. If a device is affected, it should be removed from service and returned to Zimmer or the distributor for replacement or refund. No specific instructions for immediate patient action are provided in the source text, but medical professionals should consult the recall details for clinical guidance.
The recalled product
- Product
- MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
- 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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