Knee replacement implant recalled due to potential material degradation
Howmedica Osteonics recalls DUR PCA MTK REV INS RT knee replacement implants due to potential oxidation of UHMWPE material that could compromise material properties. Patients should contact their healthcare provider.
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 involving a knee replacement implant made with potentially oxidized material that can impact material properties. No injuries or illnesses have been reported. Per the rubric, a risk-of-harm product without reported injury scores 3 (High).
Plain-English summary
Howmedica Osteonics Corp. is recalling certain DUR PCA MTK REV INS RT knee replacement implants. The product was manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material that was over 5 years of age. Raw material of this age has the potential to develop elevated levels of oxidation, which can negatively impact the material's properties.
The affected implants were distributed nationwide and to multiple countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, United Kingdom, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, Spain, and the Netherlands. Lot number 51828501 is affected.
Patients with this implant should contact their healthcare provider or orthopedic surgeon to discuss whether their implant may be affected and what monitoring or follow-up may be appropriate.
The recalled product
- Product
- DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
- 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: 04546540322944 Lot Numbers: 51828501
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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