Z-2019-2023Class II

AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

Name: Z-2019-2023 AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Creator: Tornier, Inc
Published: 2023-06-12
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2023-06-12 / Open, Classified / root cause: labeling and UDI

FDA source

Tornier, Inc began a recall of AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 on 2023-06-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2019-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-12
Posted: 2023-06-28
Recalling firm: TORNIER Inc.
Product: AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 55 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2019-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2019-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-28
Z-2020-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-28

Product code KWS

K191318Class IIAEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc. / cleared 2019-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)