Recall Z-2025-2021 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Tornier, Inc
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
| Date | May 28, 2021 |
| Status | Terminated |
| 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 p |
| Quantity | 20 |
| Distribution | IL and TX Belgium, France and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122698 | AEQUALIS ASCEND FLEX SHOULDER SYSTEM Tornier S.A.S., Jan 8, 2013 |