Zimmer Recalls Humeral Intramedullary Nails Due to Packaging Validation Issues
Zimmer is recalling 7,044,680 humeral intramedullary nails 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) because the packaging passed seal integrity testing, and no illnesses or injuries are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling 7,044,680 units of M/DN Humeral I/M Nails (sizes 6 mm to 13 mm) with codes starting with 0022541, 002542, and 0022543. The affected devices 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 tray configurations met the acceptance criteria for sterile barrier integrity (99% reliability with a 90% confidence interval), Zimmer decided to recall all non-expired lots sterile packaged in that specific facility to ensure safety.
The affected products were distributed worldwide, including in the United States and numerous international markets. Healthcare providers and patients should contact Zimmer or their local FDA office for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
- 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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