Knee implant Recall: Howmedica Osteonics Trident 28mm Insert
Affected TRIDENT UHMWPE inserts were manufactured from UHMWPE aged in excess of five years, with potential for elevated oxidation. This oxidation may result in increased wear, debris, fragments, fractured device, or disassociated device, possibly requiring revision surgery, and causing pain or inflammation. About 12,156 US devices are affected, with worldwide distribution including the US and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
| Brand | Howmedica Osteonics Corp. |
|---|---|
| Product | TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene) |
| Reason | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation. |
| Severity | moderate |
| Units affected | 12156 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Consult your orthopedic surgeon to verify whether your implant is the TRIDENT 28mm insert.
- If you experience symptoms such as pain, swelling, instability, or reduced function, seek prompt medical evaluation.
- Keep your implant details (model/size/UDI if available) and recall information handy and follow your clinician's guidance.
- Do not attempt self-removal or modification of the implant; follow professional medical advice and recall instructions.
How to identify the recalled item
| Lot / date codes | 620-00-28D UDI-DI 07613327313581 Lots MHANP2 MHD1N0 |
|---|---|
| Lot / date codes | 73-2710 UDI-DI 07613327033847 Lot NPPV 73-2910 UDI-DI 07613327033854 Lot 14AGFD 73-3110 UDI-DI 07613327033861 Lots 1L45 4JM5 7EL5 AME3 MK74 NTV7 PYHM RE7J VEWJ 73-3508 UDI-DI 07613327033885 Lots HMM5 NLRE 73-3708 UDI-DI 07613327033892 Lots 3467 3D8D PMRHX1 T6YJ T9ME VWDA YAM7 73-3710 UDI-DI 07613327033908 Lots 3W25 DLYP 73-3910 UDI-DI 07613327033915 Lots 14NEYA 1XED 9Y3T D1M9 D2YP EX8T KRT3 KRT3X1 T325 V8X8 X6YE |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other knee implant recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.