Zimmer Recalls Modular Hip Cup Liners Due to Packaging Validation Issues
Zimmer is recalling 7,044,680 modular hip cup liners because packaging operations at its Puerto Rico facility were not properly validated, despite passing 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 hazard is theoretical, as the source text explicitly states that the products met acceptance criteria for sterile barrier integrity, and no illnesses or injuries are reported.
Plain-English summary
Zimmer, Inc. is recalling approximately 7,044,680 units of modular cup liners, including neutral, 10-degree, 20-degree, and 7mm offset configurations. The affected products were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico.
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 (99% reliability with a 90% confidence interval), Zimmer decided to recall all non-expired manufacturing lots from this specific facility to ensure safety.
The affected products were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, Germany, and Japan. Healthcare providers and patients should check their inventory and patient records for these specific product codes and contact Zimmer for further instructions on handling the recalled devices.
The recalled product
- Product
- MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
- 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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