FDA Device recall Z-2025-2021
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, F…
- FDA Device
- Class II
- terminated
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, F… by Tornier, citing two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2025-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-28 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tornier |
| Distribution | IL, TX |
Product
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Reason
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Identifiers
| code_info | Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2025-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.