Knee Replacement Component Recalled for Potential Material Oxidation and Degradation
Howmedica Osteonics is recalling TRIDENT 0 deg knee implant components manufactured with aged raw material that may have elevated oxidation levels, potentially affecting 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: FDA Class II recall of an orthopedic implant component where elevated material oxidation presents a risk of harm. As no illnesses or injuries have been reported, this meets the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling TRIDENT 0 deg POLY INSERT knee replacement components, Part Number 620-00-32J, from lot number 29518001.
The recalled components were manufactured using UHMWPE raw material that is over 5 years of age. Such material has the potential for elevated levels of oxidation, which can affect the material properties of the implant.
The affected components were distributed nationwide and internationally to 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 who received these implant components should contact their healthcare provider to discuss whether additional monitoring or evaluation is recommended. Healthcare providers should verify whether they received products from the affected lot number.
The recalled product
- Product
- HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
- 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: n/a Lot Numbers: 29518001
Distribution
Distributed nationwide across the United States.
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