Zimmer Biomet Recalls Hip Implants Due to Packaging Residue
Zimmer Biomet is recalling 13,227 hip implants because LDPE packaging may leave residue on the polished surface.
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: This is a Class II recall involving a packaging defect that may leave residue on the implant. No injuries or illnesses are reported, and the hazard is a potential contamination rather than a structural failure or high-risk pathogen.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of CPT 12/14 COCR Size 2 Extension hip prostheses. These are semi-constrained, metal/polymer, porous uncemented implants. The recall covers specific lot numbers and item number 00-8114-002-10.
The recall is due to a packaging issue where the LDPE bag may adhere to the highly polished surface of the implant. This adhesion can leave residue or material from the bag on the implant after it is removed. The affected products were distributed nationwide in the US and in 24 other countries, including Argentina, Australia, Brazil, and Canada.
Healthcare providers and facilities should check their inventory for the specific item and lot numbers listed in the recall notice. Patients who have already had these implants placed should contact their healthcare provider for guidance.
The recalled product
- Product
- CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 13,227
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 48 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.
See all 48 products in this recall →Related recalls
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