Z-3206-2026Class II
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910...
Howmedica Osteonics Corp. / initiated 2026-07-30 / Open, Classified
Recall record
- Recall number
- Z-3206-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Product code
- NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- 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 root cause
- Process change control
- Action
- 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.
- Quantity in commerce
- 12,156 US
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-3195-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3196-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3197-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3198-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3199-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3200-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3201-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3202-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3203-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3204-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3205-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3206-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.