FDA recall Z-1237-2026

Product

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2025-12-19

Report date

2026-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2026