Zimmer Recalls 6 Degree COCR Femoral Heads Due to Packaging Validation Issues
Zimmer is recalling 6 Degree COCR Femoral Heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 (potential sterile barrier compromise) as the product passed seal integrity testing and no illnesses or injuries are reported, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 6 Degree COCR Femoral Heads (36mm) due to a review of historic packaging validations at its Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The review determined that packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing showed that the packaging met acceptance criteria for sterile barrier integrity, Zimmer has decided to recall all unexpired lots sterile packaged in this specific facility.
The recall affects 7,044,680 units distributed worldwide, including the United States and numerous international markets such as Canada, the United Kingdom, and various European and Asian countries. The source text does not specify the exact dates of distribution or the specific lot numbers affected, though a list of codes is provided in the structured data.
Consumers and healthcare providers should check their inventory for these specific femoral heads. If the product was sterile packaged in the ZMBV facility Building 1 packaging operations and has not expired, it should be removed from use and returned to Zimmer, Inc. according to their recall instructions.
The recalled product
- Product
- 6 DEGREE COCR FEM HEAD 36
- 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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