Recall Z-1237-2026 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Tornier, Inc
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
| Date | Feb 2, 2026 (initiated Dec 19, 2025) |
| Status | Open, Classified |
| Reason | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery. |
| Root cause | Labeling mix-ups |
| Action | On December 19, 2025, the firm began notifying affected customers via Urgent Field Safety Notice letters. Customers were instructed to immediately check their internal inventory for affected product. Firm stated that return of product is not necessary because the issue is detectable pre-operatively. The physical product itself is correctly marked, and after unpacking, should only be assigned to the correct place in the screw caddy. The notification is being provided for awareness only. |
| Quantity | 427 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid Tornier, Inc., Nov 15, 2016 |