Z-1237-2026 Class II Ongoing
FDA device recall Z-1237-2026 was initiated by Tornier, Inc on December 19, 2025 and is designated Class II. 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 surger… The recall status is ongoing. Affected quantity: 427.
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2026
- Initiation Date
- December 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 427
Product Description
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot AZ4824290