Knee Replacement Implant Recalled Due to Potential Material Oxidation Risk
Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.
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 device recall with no reported injuries or illnesses. However, the hazard involves a medical implant with potential material property degradation due to oxidation, making it a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity classification.
Plain-English summary
Howmedica Osteonics Corp. is recalling certain RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT knee replacement implants (Product Number 6637-0-928) that were manufactured using UHMWPE raw material over 5 years of age.
Oxidation in aged UHMWPE material can impact material properties, potentially affecting the durability and long-term performance of the implant.
The recalled implants (lot number 41875401) were distributed nationwide and to multiple countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, Venlo (Netherlands), Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Patients who have received this implant should contact their healthcare provider or Howmedica Osteonics Corp. for guidance about their individual situation.
The recalled product
- Product
- RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
- 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: 04546540306463 Lot Numbers: 41875401
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.
See all 58 products in this recall →Related recalls
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