medical Class II Updated 2021-07-21

Tornier, Inc recalls Aequalis Ascend Flex Shoulder System Reversed Platform (Reve

Recalled Product

Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.


Hazard / Issue

Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

Issued by

FDA

Affected States: IL, TX
Lot/Code Info: Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25
View official government recall

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