Recall Z-3203-2026 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 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
| K033972 | SCORPIO TOTAL KNEE SYSTEM Howmedica Osteonics Corp., Apr 12, 2004 |