FDA recall Z-2019-2023

Product

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.

Key facts

Status

Ongoing

Initiation date

2023-06-12

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2019-2023