Knee Replacement Inserts Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling PRIMARY REV.TIB.INSERT-DURACON knee replacement inserts manufactured with aging UHMWPE material that has potential for oxidation affecting material properties. Affected lots: 36273601 and 36609701.
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 affecting a high-risk implanted medical device without any reported injuries or device failures. The hazard—material oxidation in a structural component—is a theoretical but credible risk that could affect implant durability. Per the rubric, risk-of-harm products where injury has not been reported warrant a score of 3.
Plain-English summary
Howmedica Osteonics Corp. is recalling PRIMARY REV.TIB.INSERT-DURACON knee replacement inserts (Product Number 6637-4-031, GTIN 04546540306920) because these devices were manufactured using UHMWPE raw material that was over 5 years of age. Material of this age has the potential for elevated levels of oxidation, which can impact the insert's material properties and performance.
The affected lot numbers are 36273601 and 36609701. These devices have been distributed nationwide and internationally, including to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and the Netherlands. As of January 25, 2024, distribution was expanded to include Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Patients who have received this implant should contact their surgeon or healthcare provider to discuss whether their specific implant is affected by this recall and to determine if any additional evaluation or follow-up is necessary.
The recalled product
- Product
- PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
- 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: 04546540306920 Lot Numbers: 36273601
- 36609701
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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