Knee replacement tibial insert recalled for potential material oxidation
Howmedica Osteonics Corp. is recalling Series II tibial bear inserts used in knee replacements. Raw material over 5 years old 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: This is a Class II FDA recall of a knee replacement component where material oxidation in aged raw material presents potential for material property degradation in an implanted device. As a risk-of-harm product without reported injuries, this qualifies as a High severity recall.
Plain-English summary
Howmedica Osteonics Corp. is recalling the SERIES II TIBIAL BEAR INSERT (Part Number 3052-0524), a component used in knee replacement surgery. The recall affects units manufactured using raw material (UHMWPE) that is over 5 years of age.
The company is conducting this recall because aged raw material has the potential for elevated levels of oxidation. Oxidation within the UHMWPE material can impact its material properties, which could affect the performance and durability of the implant.
The affected devices were distributed nationwide in the United States 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. The lot affected is K349TP.
The recalled product
- Product
- SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- material-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: 07613327034073 Lot Numbers: K349TP
Distribution
Distributed nationwide across the United States.
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