WhichRecall
Class IIReported 2026-02-11

TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

Recalled by Tornier, Inc

Reason for Recall

A specific lot of screws is incorrectly labeled

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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.

Recall Number
Z-1237-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-19
Reported
2026-02-11
Distribution
US Nationwide distribution.
Code Info
Lot AZ4824290
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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