Knee Replacement Implant Recall Due to Potential Material Oxidation
Howmedica Osteonics Corp. is recalling LARGE PRIMARY REV.TIB.INSERT-DURACON knee implants manufactured with aged UHMWPE material that may have elevated oxidation levels. Affected patients should consult 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: FDA Class II recall of orthopedic implant where manufactured material may have elevated oxidation levels. No illnesses or injuries reported. Classified as High per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling LARGE PRIMARY REV.TIB.INSERT-DURACON (Product Number 6637-4-231), a tibial insert used in knee replacement surgery. The recall affects implants manufactured using UHMWPE raw material that is over 5 years old, with lot number 33164901.
The UHMWPE material used in these implants may experience elevated levels of oxidation, which can impact the material's properties. Oxidation of this polymer can affect the implant's long-term performance.
The affected implants have been distributed nationwide in the United States and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Patients and healthcare providers should contact Howmedica Osteonics Corp. for additional information. Patients who have received this implant should consult with their healthcare provider to discuss any concerns or next steps.
The recalled product
- Product
- LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
- 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: 04546540307101 Lot Numbers: 33164901
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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