Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AEQUALIS FLEX REVIVE Assembly Screw 0mm Recalled by Tornier, Inc Due to A comingle/swap resulted in the labeling and laser...

Date: June 12, 2023
Company: Tornier, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tornier, Inc directly.

Affected Products

AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

Quantity: 55 units

Why Was This Recalled?

A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Tornier, Inc

Tornier, Inc has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report