FDA DevicesClass II
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ3...
Published: February 11, 2026Recall ID: Z-1237-2026Category: devicesCountry: US
Reason for Recall / Hazard
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 & Identification
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Additional Source Details
| Field | Value |
|---|---|
| City | Bloomington |
| State | MN |
| Event id | 98123 |
| Address 1 | 10801 Nesbitt Ave S |
| Address 2 | N/A |
| Code info | Lot AZ4824290 |
| Postal code | 55437-3109 |
| Report date | 20260211 |
| Product type | Devices |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | Letter |
| Center classification date | 20260202 |
Overview
- Recalling FirmTornier, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.