FDA-Device2023-07-05Class II
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
Tornier, Inc
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.
Affected count
55 units
Manufactured in
10801 Nesbitt Ave S, N/A, Bloomington, MN, United States
Products
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2020-2023Don't want to check this manually?
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