FDAHealthDecember 19, 2025
Tornier, Inc — TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 19, 2025
US Nationwide distribution.
What's affected?
- Product
- TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
- Brand
- Tornier, Inc
- Lot code
- AZ4824290
Additional details
Lot AZ4824290
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 427.
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