Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE Recalled by Tornier, Inc Due to A specific lot of screws is incorrectly labeled....
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tornier, Inc directly.
Affected Products
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Quantity: 427
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tornier, Inc
Tornier, Inc has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report