Knee Replacement Implant Components Recalled for Material Degradation Risk
Howmedica Osteonics Corp. is recalling specific lots of knee replacement implant components manufactured with aged raw material. The UHMWPE material may experience oxidation that could affect its structural 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: This is a risk-of-harm implanted medical device where material degradation presents a potential safety concern. However, no reported injuries, failures, or illnesses have been documented. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).
Plain-English summary
Howmedica Osteonics Corp. is recalling specific lots of a knee replacement implant component designated as LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT (Product Number 6637-0-631). The affected lots are 36272501, 42380501, and 42771601.
The product was manufactured using Ultra-High Molecular Weight Polyethylene (UHMWPE) raw material over 5 years of age. Aged raw material of this type has the potential for elevated oxidation levels, which can impact the material's structural and mechanical properties, potentially affecting device performance.
The product has been distributed nationwide in the United States and to multiple countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, the Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
No injuries or implant failures have been reported to date. Patients implanted with these components should contact their healthcare provider if they experience any concerns or complications related to their knee replacement.
The recalled product
- Product
- LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
- 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 (2)
- GTIN: 04546540306203 Lot Numbers: 36272501
- 42380501 42771601
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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