Z-2025-2021Class II

Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer...

Name: Z-2025-2021 Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer...
Creator: Tornier, Inc
Published: 2021-05-28
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2021-05-28 / Terminated / root cause: manufacturing process

FDA source

Tornier, Inc began a recall of Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder... on 2021-05-28. FDA classified it as Class II and gives the reason as "Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2025-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-28
Posted: 2021-07-12
Terminated: 2023-04-14
Recalling firm: TORNIER Inc.
Product: Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Consignees were sent a Tornier "Urgent-Field Safety Notice - Medical Device Recall" letter dated May 28, 2021. The letter was addressed to Healthcare professionals and distributors. The letter described the problem and product involved. Advised consignees to immediately discontinue use of the affected product and to return any unused affected product to their facility. Advised their distributors to notify all accounts. They also attached a questionnaire needed for inventory status.Immediately quarantine all recalled products they have and return all affected product to Tornier SAS as soon as possible. If they have further distributed the affected product, we are asking them to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and Tornier SAS will work directly with them to collect the recalled items. If you have any questions or concerns, please do not hesitate to contact the undersigned or contact Customer Service +1 888 494 7950.
Quantity in commerce: 20
Distribution: IL and TX Belgium, France and United Kingdom
Product codes and lots: Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2025-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2025-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-21	2021-07-12

Product code KWS

K122698Class IIAequalis Ascend Flex Shoulder SystemTornier S.A.S. / cleared 2013-01-08

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)