Zimmer Recalls Modular Austin Moore Femoral Neck Implants Due to Packaging Validation
Zimmer is recalling Modular Austin Moore Femoral Neck implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent 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 a theoretical risk related to packaging validation rather than a confirmed defect or reported injury, fitting the criteria for a voluntary precautionary recall with low-risk contamination concerns.
Plain-English summary
Zimmer, Inc. is recalling Modular Austin Moore Femoral Neck implants (item codes starting with 45502001, 455503001, and 455504001). 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 sterile packaged in that specific facility.
Healthcare providers and patients should contact Zimmer for further instructions regarding the affected devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
- 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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