PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: February 11, 2026 Initiated: December 19, 2025 #Z-1237-2026

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.

Details

Recalling Firm
Tornier, Inc
Units Affected
427
Distribution
US Nationwide distribution.
Location
Bloomington, MN

Frequently Asked Questions

What product was recalled?
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318. Recalled by Tornier, Inc. Units affected: 427.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1237-2026.