FDA Medical Device Recalls (openFDA)
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 number
- Z-2025-2021
- Recalling firm
- Tornier, Inc
- Product
- Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
- Status
- Terminated
- Initiated
- 2021-05-28
- Posted
- not on file
- Terminated
- 2023-04-14
- Reason
- Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 20
- Distribution
- IL and TX Belgium, France and United Kingdom
- Lot, serial or model codes
- Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25
- 510(k) numbers
- ["K122698"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 3000718467
- Firm city
- Bloomington
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28