Knee Replacement Insert May Degrade from Oxidized Raw Material
Howmedica Osteonics is recalling PS LIPPED TIBIAL INSERT ASSY DURACON knee replacement inserts manufactured with UHMWPE raw material over 5 years old. The aged material may develop elevated oxidation that could impact 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 an FDA Class II recall for an implanted orthopedic device where no illnesses or injuries have been reported. The material degradation poses a theoretical risk of device failure in knee replacements, consistent with a risk-of-harm product where injury has not yet been documented.
Plain-English summary
Howmedica Osteonics Corp. is recalling PS LIPPED TIBIAL INSERT ASSY DURACON components (Product Number 6742-1-413) intended for knee replacement. The affected products were manufactured using UHMWPE raw material that exceeded 5 years of age.
UHMWPE (ultra-high-molecular-weight polyethylene) can develop elevated oxidation levels when aged. Oxidation can impact the material's properties, which are important to the performance and longevity of the knee replacement insert.
The recall affects products with lot numbers 559469, 561926, and 584958, distributed nationwide and internationally including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, United Kingdom, Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
The recalled product
- Product
- PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
- 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 (3)
- GTIN: 04546540324115 Lot Numbers: 559469
- 561926
- 584958
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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