Knee replacement implants recalled for potential material degradation
Howmedica Osteonics Corp. is recalling DURATION Plastic Patella knee replacement implants due to potential oxidation in UHMWPE raw material over 5 years old, which may affect implant durability.
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 material integrity issue in an orthopedic implant. While the UHMWPE oxidation presents a potential risk to implant durability and performance, no injuries or illnesses have been reported, which per the rubric limits this to High severity rather than Severe.
Plain-English summary
Howmedica Osteonics Corp. is recalling DURATION Plastic Patella knee replacement implants nationwide. The recalled product is manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material that is more than 5 years of age.
The recall was initiated because UHMWPE material over 5 years of age has the potential to develop elevated levels of oxidation. Oxidation within the material can affect its properties and integrity, potentially impacting the long-term performance of the implant.
The recalled implants were distributed nationwide and internationally to 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. The recall affects units with lot number 383541.
Patients who have received this implant should contact their healthcare provider or Howmedica Osteonics Corp. for guidance. No injuries or illnesses related to this issue have been reported to date.
The recalled product
- Product
- DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
- 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: 04546540318398 Lot Numbers: 383541
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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