Knee replacement implant recalled due to material oxidation risk
Howmedica is recalling knee replacement implants manufactured with UHMWPE material over 5 years old due to potential oxidation that could affect material properties.
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: FDA Class II recall of a high-risk joint implant with potential material degradation due to oxidation in aged UHMWPE material. The hazard is theoretical—potential impact on material properties rather than reported failures—placing it at the upper end of the Moderate-to-High range per rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling certain knee replacement implants (model RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT, Product Number 6637-0-831, Lot Number 47475901). The affected implants were manufactured using UHMWPE raw material that is over 5 years old.
The issue is potential elevated levels of oxidation in the UHMWPE material. Oxidation can degrade the material's properties, potentially affecting implant performance and durability.
The recalled implants were distributed nationwide and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Healthcare providers and patients with questions about this recall should contact Howmedica Osteonics Corp. for further information.
The recalled product
- Product
- RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
- Manufacturer
- Howmedica Osteonics Corp.
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)
- GTIN: 04546540306388 Lot Numbers: 47475901
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Howmedica Osteonics Corp. 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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