Knee replacement devices recalled due to potential material degradation
Howmedica Osteonics Corp. recalls knee replacement devices with UHMWPE components manufactured from raw material over 5 years old due to potential oxidation that may affect 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 recall of a medical device where material degradation poses a risk of harm to joint function. No illnesses, injuries, or deaths have been reported; the hazard is theoretical. Per the rubric, theoretical hazards with no reported harm are scored at most 3.
Plain-English summary
Howmedica Osteonics Corp. is recalling the DUR PCA MTK REV INS LFT knee replacement device due to potential material degradation in the ultra-high molecular weight polyethylene (UHMWPE) component.
Devices manufactured using UHMWPE raw material over 5 years of age may have elevated levels of oxidation. Oxidation can impact the material properties of UHMWPE, potentially affecting the performance and durability of the knee replacement.
The device was distributed nationwide and in multiple countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Patients who have received this device should consult with their healthcare provider. The affected lot number is 52814401.
The recalled product
- Product
- DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
- 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: 04546540322883 Lot Numbers: 52814401
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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