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

Recall date

December 19, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1237-2026

FDA classification

Class II

Brand / firm

Tornier, Inc

Sold / distributed

US Nationwide distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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