FDAClass IIJuly 21, 2021

Aequalis Ascend Flex Shoulder System Reversed Platform recall

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

Why was Aequalis Ascend Flex Shoulder System Reversed Platform recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25

Product
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France.…
Recalling firm
Tornier, Inc
Quantity
20
Distribution
IL and TX Belgium, France and United Kingdom
Recall date
July 21, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls