Zimmer Biomet Recalls Ceramic Femoral Heads Due to Packaging Adhesion
Zimmer Biomet is recalling 5.4 million ceramic femoral heads because non-highly polished implants may adhere to the LDPE bag packaging.
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, and the hazard involves a packaging issue (adhesion) 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 5,459,583 Ceramic Femoral Heads, various sizes, Item Nos. 00877504001, 00877504002, 00877504003, and 00877504004. The recall covers all products manufactured prior to January 2014 and distributed nationwide.
The recall was initiated because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue is classified as an FDA Class II recall.
Healthcare providers and facilities should contact Zimmer Biomet for instructions on how to handle the affected devices. Consumers are not directly affected as these are medical implants.
The recalled product
- Product
- Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
- 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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