Knee Implant Inserts Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.
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 medical device recall for potential material degradation in a knee implant with no reported injuries or illnesses. The hazard is theoretical but applies to a critical implant component with significant patient impact potential.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO TS TIB INSERT knee replacement implants (Part Number 72-4-0510) due to a potential material hazard. These implants were manufactured using UHMWPE raw material over 5 years of age, which has the potential for elevated oxidation levels. Oxidation within UHMWPE can impact the material's properties, which may affect the long-term performance of the implant.
The recall affects units distributed nationwide and internationally, including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. Affected lot numbers are H43RDK, WR1RE3, 768NEY, and 4J13P1 (GTIN: 07613327034363).
Patients with these implants should contact Howmedica Osteonics Corp. or their healthcare provider for information about their specific implant and any recommended follow-up actions.
The recalled product
- Product
- SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device — Knee Implant
- 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 (4)
- GTIN: 07613327034363 Lot Numbers: H43RDK
- WR1RE3
- 768NEY
- 4J13P1
Distribution
Distributed nationwide across the United States.
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