Tornier, Inc: Device Recall
Recall #Z-1237-2026 · 12/19/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1237-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Tornier, Inc
- Status
- Ongoing
- Date Initiated
- 12/19/2025
- Location
- Bloomington, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 427
Reason for Recall
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.
Product Description
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Distribution Pattern
US Nationwide distribution.
Other Recalls by Tornier, Inc
- Class II: Risk 03/03/2025
- Class II: Risk 08/29/2024
- Class II: Risk 08/29/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.