Tornier, Inc recalls TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1237-2026
• FDA 510(k) clearance · K161742The device's official FDA premarket clearance record
• FDA device classification · KWSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Tornier, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.