Tornier, Inc Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Brand
Tornier, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25
Tornier, Inc is recalling Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Ma due to Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Recommended Action
Per FDA guidance
Consignees were sent a Tornier "Urgent-Field Safety Notice - Medical Device Recall" letter dated May 28, 2021. The letter was addressed to Healthcare professionals and distributors. The letter described the problem and product involved. Advised consignees to immediately discontinue use of the affected product and to return any unused affected product to their facility. Advised their distributors to notify all accounts. They also attached a questionnaire needed for inventory status.Immediately quarantine all recalled products they have and return all affected product to Tornier SAS as soon as possible. If they have further distributed the affected product, we are asking them to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and Tornier SAS will work directly with them to collect the recalled items. If you have any questions or concerns, please do not hesitate to contact the undersigned or contact Customer Service +1 888 494 7950.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, TX
Page updated: Jan 10, 2026