Knee Replacement Implants Recalled for Potential Material Oxidation
Howmedica Osteonics Corp. is recalling knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material has potential for elevated oxidation levels, which could affect the implant's 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: FDA Class II medical device recall for a risk-of-harm orthopedic implant with potential material degradation. No injuries have been reported in the source text. The hazard is theoretical—based on potential oxidation affecting material properties—so the score does not exceed 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling the DUR PCA MTK REV INS LFT knee replacement implants (Product Number 6728-2-609). These orthopedic implants are intended for use in knee replacement procedures.
The recall affects products manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material that exceeded 5 years of age at the time of manufacturing. Material of this age has the potential for elevated oxidation levels, which can impact the implant's material properties.
The affected lot number is 50884601. These implants have been distributed nationwide in the United States and internationally to numerous countries including 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.
Patients who have received these implants should consult with their healthcare provider about any concerns. Healthcare providers should report any adverse events or patient issues potentially related to this recall to the FDA MedWatch program.
The recalled product
- Product
- DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
- 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: 04546540322876 Lot Numbers: 50884601
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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