Zimmer Recalls 6 Degree Femoral Heads Due to Packaging Validation Issues
Zimmer is recalling 6 Degree COCR Femoral Heads and 6 Degree Unipolar Femoral Heads because packaging operations at a Puerto Rico facility were not properly validated.
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: This is a voluntary precautionary recall based on a validation documentation issue where the product passed subsequent integrity testing, and no injuries or illnesses are reported.
Plain-English summary
Zimmer, Inc. is recalling 6 Degree COCR Femoral Heads (various sizes) and 6 Degree Unipolar Femoral Heads. The recall involves 7,044,680 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated after Zimmer reviewed 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 trays met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots that were sterile packaged in that specific facility.
Patients who have had these devices implanted should contact their healthcare provider for guidance. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
- 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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