Device product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Z-1237-2026
Product summary
- Firm
- Tornier, Inc
- Event
- Event 98123
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 427
- Official record key
device-enforcement:Z-1237-2026
Official wording
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 information: Lot AZ4824290
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
incorrectly labeled