Tornier, Inc: Medical Device Recall in 2021 - (Recall #: Z-2025-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

Product Classification:

Class II

Date Initiated: May 28, 2021

Date Posted: July 21, 2021

Recall Number: Z-2025-2021

Event ID: 88004

Reason for Recall:

Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

Status: Terminated

Product Quantity: 20

Code Information:

Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25

Distribution Pattern:

IL and TX Belgium, France and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated