Recall Z-3206-2026 · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
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)
| Date | Sep 16, 2026 (initiated Jul 30, 2026) |
| Status | Open, Classified |
| 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. |
| 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 | 12,156 US |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051948 | AVON PATELLO-FEMORAL JOINT PROSTHESIS Howmedica Osteonics Corp., Oct 21, 2005 |
| K052917 | STRYKER COMPARTMENTAL KNEE SYSTEM Howmedica Osteonics Corp., Dec 27, 2005 |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpi Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Feb 6, 2025 |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathl Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Dec 15, 2025 |