Recall Z-2025-2021— Tornier, Inc
Class II · Terminated
Class II FDA medical device recall by Tornier, Inc, initiated 2021-05-28, terminated 2023-04-14. It names one FDA 510(k) clearance: K122698. Product: Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.. Reason: Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness..
- Recalling firm
- Tornier, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-28
- Terminated
- 2023-04-14
- Firm location
- Bloomington, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Reason for recall
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Data sourced from openFDA. This site is unofficial and independent of the FDA.