FDA-Device2021-07-21Class II
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Tornier, Inc
Hazard
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Sold states
IL and TX Belgium, France and United Kingdom
Affected count
20
Manufactured in
10801 Nesbitt Ave S, Bloomington, MN, United States
Products
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2025-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief