Home / Recalls / Medical Devices
Tornier, Inc recalls AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Recalled July 5, 2023 · FDA recall Z-2019-2023 · Tornier
Hazard
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. · FDA Class II
Units
55 units
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.
Description
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.
Product
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Manufacturer(s)
Tornier, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →