Knee replacement tibial insert recalled due to material oxidation risk
Howmedica Osteonics Corp. is recalling DURATION knee replacement tibial inserts manufactured with raw materials over 5 years old that have developed oxidation. Oxidation can degrade the material's structural properties, affecting implant performance.
What this means for you
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 orthopedic device where material oxidation poses a risk of implant degradation and potential failure. No illnesses or injuries have been reported. Per the recall severity rubric, risk-of-harm products where injury has not yet been reported receive a High severity rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling the DURATION A-P Lipped Tibial Insert (Product Number 6642-1-709), a component used in knee replacement surgery. The recall affects products manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material that is over 5 years old.
The FDA identified that UHMWPE raw material aged over 5 years can develop elevated levels of oxidation. Oxidation within the material can impact its structural properties, potentially affecting the performance and longevity of the implant.
The affected products have been distributed nationwide in the United States 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 international distribution list was updated as of January 25, 2024.
The affected lot numbers are 52098201, 54184201, 56002801, 50677001, and 56662001 (GTIN 04546540318145). If you have received one of these units, contact Howmedica Osteonics Corp. immediately. Patients who have received this implant should consult their healthcare provider about whether their implant may be affected and what monitoring or replacement options may be appropriate.
The recalled product
- Product
- DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- material-oxidation
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 (5)
- GTIN: 04546540318145 Lot Numbers: 52098201
- 54184201
- 56002801
- 50677001
- 56662001
Distribution
Distributed nationwide across the United States.
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