Zimmer Recalls FEM HD ION Hip Implants Due to Packaging Validation Issues
Zimmer is recalling FEM HD ION hip implants because packaging operations at a 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: This is a voluntary precautionary recall based on a lack of proper validation documentation, with no reported illnesses or injuries and successful seal integrity testing.
Plain-English summary
Zimmer, Inc. is recalling FEM HD ION hip implants in various sizes. The recall involves 7,044,680 units that were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. These products were distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, France, Germany, India, Italy, Japan, and the United Kingdom.
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 Zimmer conducted seal integrity testing and the packaging tray configurations met the acceptance criteria for sterile barrier integrity, the company decided to recall all non-expired manufacturing lots from this specific operation to ensure safety.
Healthcare providers and patients should contact Zimmer for further instructions regarding the affected lots. The specific lot codes associated with this recall are: 61401713, 60282649, 60291491, 60362702, 60586125, 60977398, 61089134, 62051714, 60530561, 60759915, 60939995, 61275826, and 60169621.
The recalled product
- Product
- FEM HD ION (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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