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.
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 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.
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.
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
Same manufacturer · Howmedica Osteonics Corp.
See all →- ModerateHowmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Triathlon Instrument Trays Recalled for Sterilization Dry Time Issue
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions
FDA (Devices) · 2026-10-21
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
Same hazard · oxidation
See all →- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
- ModerateIcosapent Ethyl Capsules Recalled for Failed Tablet Specifications
FDA (Drugs) · 2025-06-18
- ModerateExactech Shoulder Implant Components Recalled for Nonconforming Oxygen Barrier Packaging
FDA (Devices) · 2024-04-10
- HighKnee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk
FDA (Devices) · 2024-02-07
- HighKnee implant component recalled due to potential material oxidation
FDA (Devices) · 2024-02-07
Similar recalls
- HighHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Trident Polyethylene Knee Inserts Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Aged Orthopaedic Implant Components Due to Wear Risk
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Triathlon Hinge Inserts Due to Material Aging
FDA (Devices) · 2026-09-23