Tornier, Inc: Medical Device Recall in 2023 - (Recall #: Z-2019-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

Product Classification:

Class II

Date Initiated: June 12, 2023

Date Posted: July 5, 2023

Recall Number: Z-2019-2023

Event ID: 92520

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.

Status: Ongoing

Product Quantity: 55 units

Code Information:

GTIN 00846832069408, Serial Numbers: AZ1822082001, AZ1822082002, AZ1822082003, AZ1822082004, AZ1822082005, AZ1822082006, AZ1822082007, AZ1822082008, AZ1822082009, AZ1822082010, AZ1822082011, AZ1822082012, AZ1822082013, AZ1822082014, AZ1822082015, AZ1822082016, AZ1822082017, AZ1822082018, AZ1822082019, AZ1822082020, AZ1822082021, AZ1822082022, AZ1822082023, AZ1822082024, AZ1822082025, AZ1822082026, AZ1822082027, AZ1822082028, AZ1822082029, AZ1822082030, AZ1822082031, AZ1822082032, AZ1822082033, AZ1822082034, AZ1822082035, AZ1822082036, AZ1822082037, AZ1822082038, AZ1822082039, AZ1822082040, AZ1822082041, AZ1822082042, AZ1822082043, AZ1822082044, AZ1822082045, AZ1822082046, AZ1822082047, AZ1822082048, AZ1822082049, AZ1822082050, AZ1822082051, AZ1822082052, AZ1822082053, AZ1822082054, AZ1822082055

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated