Knee Replacement Inserts Recalled Due to Material Oxidation Risk
Howmedica Osteonics is recalling knee replacement inserts manufactured with UHMWPE material over 5 years old, which may develop elevated oxidation levels that could affect joint stability.
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 with no reported illnesses or injuries. This qualifies as a risk-of-harm product where injury has not been reported, per the rubric criterion for Score 3.
Plain-English summary
Howmedica Osteonics Corp. is recalling LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT knee replacement components (Part Number: 6637-0-231) due to potential material degradation.
The recalled components were manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material that was over 5 years of age at the time of manufacturing. Material of this age has the potential to develop elevated levels of oxidation, which can impact the material properties of the implant.
The affected lot number is 42787901. This product was distributed nationwide and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and the Netherlands. Additional international distribution includes Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Patients who have received this implant should contact their healthcare provider or surgeon to discuss whether any action is needed regarding this recall.
The recalled product
- Product
- LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
- 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: 04546540306029 Lot Numbers: 42787901
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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