Zimmer Biomet Recalls Femorotibial and Femoral Nails Due to Packaging Adhesion
Zimmer Biomet is recalling femorotibial and femoral nails because non-highly polished implants may adhere to the previous LDPE packaging bag.
What this means for you
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, and the hazard involves a packaging issue (adhesion to LDPE bags) rather than a direct structural defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling femorotibial and femoral nails in various sizes. The recall involves 5,459,583 total devices distributed nationwide. The affected products are identified by Item Nos. 32855331111, 32855331113, 32855331115, 32855331161, 32855331163, and 32855331165, and include all products manufactured prior to January 2014.
The recall is being conducted because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This adhesion issue is the specific reason for the corrective action.
Healthcare providers and facilities should check their inventory for these specific item numbers and manufacturing dates. If the recalled devices are found, they should be removed from use and returned to Zimmer Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All products manufactured prior to January 2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Zimmer Biomet, 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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