Recall Z-2019-2023

Tornier, Inc · initiated June 12, 2023

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

Codes / lots: 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

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.

FDA-determined cause: Under Investigation by firm

Action taken

Tornier issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023 by email and letter. The notice explained the problem, the risk associated with its use, and requested that the affected devices be isolated/quarantined pending return. Distributors were directed to notify their customers.

Details

Recall number
Z-2019-2023
Initiated
June 12, 2023
Posted by FDA
June 28, 2023
Product code
KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Quantity
55 units
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.
Recalling firm
Tornier, Inc, Bloomington, MN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2020-2023 Class IIAEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex… 06/12/2023Open, Classified