Device product
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Z-2025-2021
Product summary
- Firm
- Tornier, Inc
- Event
- Event 88004
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-2025-2021
Official wording
Reason: Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
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
Derived failure modes
-
Unknown
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.