Recall Z-2019-2023— Tornier, Inc

Name: FDA recall Z-2019-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-12

Class II · Ongoing

Class II FDA medical device recall by Tornier, Inc, initiated 2023-06-12. It names one FDA 510(k) clearance: K191318. Product: AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101. Reason: 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..

Recalling firm: Tornier, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-06-12
Firm location: Bloomington, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K191318 — AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.·cleared 2019-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.