Knee Replacement Implant Insert Recalled Due to Material Degradation Risk
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement components due to potential oxidation of raw material. Material degradation could affect implant durability.
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 is an FDA Class II recall of an implanted orthopedic device with theoretical risk of material failure due to oxidation. No actual illnesses or injuries have been reported, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling the SCORPIO TS TIB INSERT, a knee replacement component intended for orthopedic surgery. The product is identified by part number 72-4-7512 and lot number 5M6LM1.
The recall was issued because UHMWPE (ultra-high-molecular-weight polyethylene) raw material used in manufacturing was over 5 years of age. Material aged beyond this threshold can develop elevated oxidation levels, which may affect the material's mechanical properties and implant performance.
The affected products were distributed nationwide and to multiple countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and the Netherlands. Additional countries including Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain received distribution as of January 2024.
The recalled product
- Product
- SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- oxidation
- implant-failure
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: 07613327034790 Lot Numbers: 5M6LM1
Distribution
Distributed nationwide across the United States.
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