Zimmer Recalls CPT 12/14 COCR Medical Devices Due to Packaging Validation Issues
Zimmer is recalling CPT 12/14 COCR devices 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, but the source text indicates that seal integrity testing met acceptance criteria and no illnesses or injuries are reported, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling approximately 7,044,680 units of CPT 12/14 COCR medical devices in various sizes. The recall affects devices that 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 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 device records to identify if they possess any of the affected lots listed in the recall notice.
The recalled product
- Product
- CPT 12/14 COCR (various sizes)
- 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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