Z-2025-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- May 28, 2021
- Termination Date
- April 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Reason for Recall
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Distribution Pattern
IL and TX Belgium, France and United Kingdom
Code Information
Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25