Knee replacement implant insert recalled due to material oxidation risk
Howmedica Osteonics is recalling Scorpio-Flex knee implant inserts manufactured with over-5-year-old UHMWPE material, which may develop elevated oxidation levels that could affect material 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 FDA Class II medical device recall concerns a structural implant component where oxidation could degrade material properties and affect device performance. No injuries have been reported in the recall notice, but the potential harm to a load-bearing joint implant warrants the High severity classification per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling Scorpio-Flex Total Knee P-S Tibial Bearing Insert Assembly units (Part Number 72-15-0324). The affected products were manufactured using UHMWPE raw material that was over 5 years of age at the time of production.
UHMWPE material aged over 5 years can develop elevated levels of oxidation. This oxidation can impact the material properties of the bearing insert, potentially affecting device performance.
The recalled devices were distributed nationwide and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, South Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, United Kingdom, Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. The affected lot number is 53867101. If you have received one of these devices, contact Howmedica Osteonics Corp. for further guidance.
The recalled product
- Product
- Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
- 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: 07613154020133 Lot Numbers: 53867101
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27