Reported Feb 11, 2026 · Ongoing
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Tornier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109
Is this the product you have?
- TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
- Lot codes and dates
- Lot AZ4824290
- Amount recalled
- 427
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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