Zimmer Biomet Recalls CPT Hip Prostheses Due to Packaging Adhesion Issue
Zimmer Biomet is recalling CPT 12/14 COCR hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
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 a packaging defect (adhesion) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling the CPT 12/14 COCR prosthesis, a semi-constrained hip implant made of metal and polymer. The recall involves 24,272 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the LDPE bag containing the implant adheres to the highly polished implant surface. This packaging defect may compromise the integrity of the device or its presentation prior to use.
Healthcare providers and patients who have received these specific hip prostheses should contact Zimmer Biomet for further instructions on how to proceed. The affected item numbers and lot numbers are listed in the official recall documentation.
The recalled product
- Product
- CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 24,272
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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 21 products in this recall →Related recalls
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