Zimmer Biomet Recalls CPT Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 289 CPT 12/14 COCR hip prostheses because the LDPE packaging bag adheres to the 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, which typically corresponds to a moderate severity score of 2, as the hazard is a packaging defect that is unlikely to cause serious injury but requires correction.
Plain-English summary
Zimmer Biomet, Inc. is recalling 289 units of the CPT 12/14 COCR prosthesis, a semi-constrained hip implant. The recall is due to a defect where the low-density polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface.
The affected product is indicated for cemented use in patients with various hip conditions, including arthritis and avascular necrosis. The recall covers specific item numbers 00-8114-040-00 and 00-8114-050-00, along with 13 specific lot numbers. The products were distributed worldwide, including in the United States and numerous international markets.
This is a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should stop using the affected units and contact Zimmer Biomet for further instructions.
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
- 289
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.
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