FDA recall Z-2025-2021

Product

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.

Distribution

IL and TX Belgium, France and United Kingdom

Key facts

Status

Terminated

Initiation date

2021-05-28

Report date

2021-07-21

Termination date

2023-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2025-2021