Tornier, Inc Recall 88004
Description: Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Tornier, Inc Recall 88004 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2025-2021 |
| Event ID | 88004 |
| Event Description | Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component. |
| Product Type | Devices |
| Distribution | IL and TX Belgium, France and United Kingdom |
| Quantity | 20 |
| Recall Reason | Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness. |
| Device Classification | 20210721 |
| Device Code Info | Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25 |
| Center Classification Date | 20210712 |
| Recall Initiation Date | 20210528 |
| Recalling Firm | Tornier, Inc |
| Initial Notification | Letter |
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