Howmedica Recalls Trident Polyethylene Knee Inserts Due to Material Aging
Howmedica Osteonics Corp. is recalling Trident polyethylene knee inserts because aged raw material may cause excessive wear and device failure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fracture/disassociation) that can lead to significant injury requiring revision surgery, meeting the criteria for a Severe rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific Trident polyethylene knee inserts (model 620-00-28D) due to a manufacturing defect involving the raw material. The affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) that was aged in excess of five years. This aging process has the potential to result in elevated levels of oxidation within the material.
The oxidation may lead to increased wear of the implant, which can cause hazards such as excessive wear debris, material fragments, a fractured device, or a disassociated device. Potential harms associated with these failures include the need for revision surgery, pain, and inflammation. The recall covers 12,156 units distributed in the United States and internationally, including Canada, LATAM, Europe, Asia Pacific, and South Africa.
Healthcare providers and patients should check their inventory or medical records for the specific model number 620-00-28D and UDI-DI 07613327313581. Affected lots include MHANP2 and MHD1N0. Patients who have had these implants should contact their orthopedic surgeon to discuss the potential risks and determine if further evaluation or intervention is necessary.
The recalled product
- Product
- TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
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)
- 620-00-28D UDI-DI 07613327313581 Lots MHANP2 MHD1N0
Distribution
Distributed nationwide across the United States.
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