Knee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk
Knee replacement tibial inserts from Howmedica may have elevated oxidation if manufactured with raw material over 5 years old, 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: Class II FDA recall for a medical device with material integrity concerns. UHMWPE oxidation can affect the material properties of a critical knee replacement component. The source reports no illnesses or injuries, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Howmedica Osteonics Corp. has recalled the DURATION A-P lipped tibial insert (Product Number 6642-1-911), a component used in knee replacement surgeries. The recall affects devices manufactured using ultra-high-molecular-weight polyethylene (UHMWPE) raw material that is over 5 years of age.
The FDA identified that UHMWPE raw material over 5 years old has the potential for elevated oxidation levels. Oxidation within the material can affect its material properties.
The recalled devices were distributed nationwide and internationally, including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and the Netherlands. Additional distribution to Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain was confirmed as of January 25, 2024. The affected lot numbers are 56000801 and 57491601.
The recalled product
- Product
- DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
- 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 (2)
- GTIN:04546540318299 Lot Numbers: 56000801
- 57491601
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.
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