⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-02-11

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Tornier, Inc
Product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-12-19
Code info
Lot AZ4824290
Product quantity
427
Voluntary mandated
Voluntary: Firm initiated
City
Bloomington
State
MN
Country
United States
Event id
98123
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