Knee replacement implant insert recalled due to material degradation risk
Howmedica Osteonics Corp. is recalling a knee replacement implant insert due to potential material oxidation. UHMWPE raw material over 5 years old may develop elevated oxidation levels, affecting implant 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 without reported illnesses, injuries, or deaths. The hazard is theoretical—potential oxidation-related material property degradation in an orthopedic implant. Per the rubric, recalls without reported adverse outcomes score at most 3 (High).
Plain-English summary
Howmedica Osteonics Corp. is recalling the LEFT SMALL-PCA Modular Revision Durable Revision Insert (Part Number 6637-0-028), a component used in knee replacement surgeries. The product was manufactured using UHMWPE raw material.
The recall was initiated because UHMWPE raw material over 5 years of age has the potential to develop elevated levels of oxidation. Oxidation within the material can have an impact on its material properties, potentially affecting the performance of the implant.
The recalled lot number is 42771401. The product has been distributed nationwide in the United States and to multiple countries 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.
Patients who have received this implant should consult their healthcare provider. Healthcare providers should stop distributing the affected lot and seek further instructions from Howmedica Osteonics Corp.
The recalled product
- Product
- LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
- 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: 04546540305831 Lot Numbers: 42771401
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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