FDA Enforcement
Class II
Ongoing
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Recall: Z-1237-2026
·
Reported February 11, 2026
Enforcement
- Recall Number
- Z-1237-2026
- Event ID
- 98123
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Tornier, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 11, 2026
- Initiation Date
- December 19, 2025
- Classification Date
- February 2, 2026
- Address
- 10801 Nesbitt Ave S, N/A, Bloomington, MN, 55437-3109, United States
Description
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
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.
Code Info
Lot AZ4824290
Distribution
US Nationwide distribution.
Quantity
427