Knee Replacement Component Recalled for Potential Material Oxidation
Howmedica Osteonics is recalling PS Lipped Tibial Insert Assy knee replacement components manufactured with UHMWPE material older than 5 years due to potential oxidation affecting performance.
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 medical device recall for a risk-of-harm product (knee replacement component). The source describes a potential material degradation issue with no reported illnesses or injuries, matching the Score 3 rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling the PS Lipped Tibial Insert Assy Duracon (Product Number 6742-1-411), a component used in knee replacement surgery. The recall affects units manufactured using UHMWPE raw material that is more than 5 years of age.
The raw material may experience elevated levels of oxidation. Oxidation can impact the material's properties, which could affect the component's performance in the knee replacement.
The recalled components have been 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 affected lot number is 584223 (GTIN: 04546540324108).
Patients who received knee replacements with these components should consult their surgeon. Healthcare providers should verify whether any inventory contains components from the affected lot number.
The recalled product
- Product
- PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
- 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: 04546540324108 Lot Numbers: 584223
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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