Knee replacement implant recall due to material oxidation risk
Howmedica Osteonics is recalling knee replacement implants manufactured with aged UHMWPE raw material that may have elevated oxidation levels, which could degrade the material's mechanical 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 Class II medical device recall involves a theoretical hazard—material degradation from oxidation—with no reported injuries or illnesses. Per the severity rubric, a risk-of-harm product without reported injury qualifies as High severity.
Plain-English summary
Howmedica Osteonics Corp. is recalling LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT knee replacement implants (product number 6637-0-328, lot number 42579701). These devices are intended for use in knee replacement surgery.
The recall concerns products manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material that was more than 5 years old at the time of manufacturing. Material aged beyond 5 years may develop elevated oxidation levels, which can degrade the material's mechanical properties.
The recalled implants have been distributed nationwide in the United States and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, United Kingdom, Netherlands, and additional countries including Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. Patients who received this implant and healthcare providers should contact Howmedica Osteonics Corp. for additional information about the recall.
The recalled product
- Product
- LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
- 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: 04546540306104 Lot Numbers: 42579701
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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