Knee replacement implant recalled for potential material oxidation risk
Howmedica Osteonics is recalling the DUR PCA MTK REV INS RT knee replacement implant manufactured with UHMWPE material over 5 years old. The material can develop elevated oxidation levels that may degrade its properties.
What this means for you
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 medical device recall involves a structural implant where material degradation poses a potential risk of harm to patients, fitting the criterion 'risk-of-harm products where injury has not yet been reported.' Although FDA Class II and no illnesses have been reported, oxidation-induced property degradation in a weight-bearing knee implant represents a significant safety concern.
Plain-English summary
Howmedica Osteonics Corp. is recalling the DUR PCA MTK REV INS RT knee replacement implant (Product Number 6728-2-711, Lot Number 52177701). The product is intended for use in knee replacement procedures.
Products manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material over 5 years of age have the potential for elevated levels of oxidation. Oxidation within the UHMWPE material can impact its material properties, which is a concern for a structural implant.
The affected implant lot has been distributed nationwide 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. Patients with questions should contact their healthcare provider or the manufacturer.
The recalled product
- Product
- DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- oxidation
- material-degradation
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: 04546540322951 Lot Numbers: 52177701
Distribution
Distributed nationwide across the United States.
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