PS Lipped Tibial Insert Assy Duracon Knee Implant Oxidation Risk
Howmedica Osteonics is recalling PS Lipped Tibial Insert knee replacement components manufactured with aged UHMWPE material that may develop oxidation, potentially affecting device properties and 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 medical device recall with no reported illnesses or injuries. However, material oxidation in UHMWPE knee implants represents a risk-of-harm to patients where degradation could compromise device integrity and joint function. Per the rubric, a theoretical risk-of-harm product without reported adverse events receives a High severity rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling PS Lipped Tibial Insert Assy (Duracon), a prosthetic insert component used in knee replacement surgeries with product number 6742-1-416.
The recall was initiated after the company identified that certain units were manufactured using UHMWPE raw material that was over 5 years of age. Material of this age has the potential to develop elevated oxidation levels, which can degrade the polyethylene's material properties and impact the device's mechanical performance.
The recalled components were distributed nationwide in the United States and internationally. Affected lot numbers are 571630, 582549, and 584840. Patients implanted with components from these lot numbers should contact their surgeon or orthopedic healthcare provider for guidance on whether monitoring or replacement is indicated.
The recalled product
- Product
- PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- oxidation
- material-degradation
- implant-failure
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 (3)
- GTIN: 04546540324122 Lot Numbers: 571630
- 582549
- 584840
Distribution
Distributed nationwide across the United States.
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