Zimmer Biomet Recalls Cephalomedullary Nails Due to Packaging Adhesion
Zimmer Biomet is recalling 5.4 million cephalomedullary nails because non-highly polished implants may adhere to the packaging bags.
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, which typically indicates a temporary or medically reversible adverse health consequence. The specific hazard is packaging adhesion, which is a quality control issue rather than a direct structural failure or contamination, fitting the Moderate severity criteria for low-risk contamination or precautionary measures.
Plain-English summary
Zimmer Biomet, Inc. is recalling approximately 5,459,583 Cephalomedullary Nails (CMN) in various sizes. The recall covers all products manufactured prior to January 2014, which were distributed nationwide.
The recall was initiated because non-highly polished implants may adhere to the low-density polyethylene (LDPE) bags used in the previous packaging configuration. This adhesion issue is the specific defect identified in the recall notice.
Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer Biomet for further instructions on how to proceed with the recall.
The recalled product
- Product
- Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 47249318114 47249318209 47249318210 47249318211 47249318213 47249318214 47249318309 47249318310 47249
- 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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