Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue
Zimmer Biomet is recalling specific hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical implant) where the hazard is the presence of foreign material residue, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of CPT 12/14 COCR Size 1 EXT hip prostheses and various highly polished hip and knee implants. The recall is due to a defect in the LDPE bag packaging, which may adhere to the highly polished surface of the implants. This adhesion can leave residue or material from the LDPE bag on the implant after it is removed from the packaging.
The affected products are distributed worldwide, including in the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, China, India, Japan, and others. The specific item number for the recalled hip prosthesis is 00-8114-001-10, with lot number 61767833.
Healthcare providers and patients should check their inventory and medical records for these specific product codes. If you have received or are using these implants, contact your healthcare provider or Zimmer Biomet for further instructions on how to proceed.
The recalled product
- Product
- CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 13,227
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)
- Item Number: 00-8114-001-10 Lot Number: 61767833
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.
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