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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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.
Part of a larger recall action
This product is one of 58 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 58 products in this recall →Related recalls
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