Recall Z-3200-2026 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Howmedica Osteonics Corp.
DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER - GLENOID #7 5361-6107 SHOULDER - GLENOID #9 5361-6109 SHOULDER - KEELED GLENOID #11 5361-6211 SHOULDER - KEELED GLENOID #5 5361
| 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
| K962082 | OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT Osteonics Corp., Aug 13, 1996 |