Recall Z-3204-2026
Howmedica Osteonics Corp. · initiated July 30, 2026
Product
TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Codes / lots: 620-00-28D UDI-DI 07613327313581 Lots MHANP2 MHD1N0
Reason for recall
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.
FDA-determined cause: Process change control
Action taken
Firm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.
Details
- Recall number
- Z-3204-2026
- Initiated
- July 30, 2026
- Posted by FDA
- September 16, 2026
- Product code
- MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Quantity
- 12,156 US
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Recalling firm
- Howmedica Osteonics Corp., Mahwah, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3195-2026 | AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3196-2026 | OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3197-2026 | ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3198-2026 | TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3199-2026 | ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3200-2026 | DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3201-2026 | ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3202-2026 | BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3203-2026 | SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3205-2026 | SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3206-2026 | SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |