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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