TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
FDA Recall #Z-1237-2026 — Class II — December 19, 2025
Product Description
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
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.
Recalling Firm
Tornier, Inc — Bloomington, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
427
Distribution
US Nationwide distribution.
Code Information
Lot AZ4824290
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated