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Aequalis™ Ascend™ Flex DWF718A

by Tornier, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03700386945496 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • 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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Aequalis™ Ascend™ Flex
Generic Name
Total reverse shoulder prosthesis
Model / Reference
DWF718A
Primary DI / UDI-DI
03700386945496
FDA Product Code
KWS
GMDN Term
Total reverse shoulder prosthesis
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
Not in Commercial Distribution
Size
Angle — 127.5 degree
Length — 120 Millimeter

Related devices

Category: Total reverse shoulder prosthesis

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No