Aequalis Ascend Flex Shoulder System

• • Terminated Z-2025-2021 FDA Class II ·initiated 28 May 2021

  Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

• • Terminated Z-0405-2020 FDA Class II ·initiated 18 Oct 2019 ·on shared 510(k) K122698

  During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K122698 ↗

FDA Product Code

KWS

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• BLUEPRINT Patient Specific Instrumentation

  Class II

  FDA 510(k) K160555 Active Cleared 10 Jun 2016

• Aequalis(Tm) Ascent(Tm) Flex Shoulder System

  Class II

  FDA 510(k) K140082 Active Cleared 18 Jul 2014

• 611 Ankle Fusion Nail

  Class II

  FDA 510(k) K130051 Active Cleared 15 Jul 2013

• Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prothesis

  Class II

  FDA 510(k) K131231 Active Cleared 16 Oct 2013

• Blueprint Mixed Reality system Open recall

  Class II

  FDA 510(k) K222510 Active Cleared 20 Jan 2023

• BLUEPRINT™ Patient Specific Instrumentation

  Class II

  FDA 510(k) K232265 Active Cleared 21 Feb 2024

See all devices from Tornier S.A.S. →