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Aequalis™ Fx2 DWH541B

by Tornier, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number03700386953002 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0699-2017 FDA Class II initiated 19 Sep 2016

    Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Aequalis™ Fx2
Generic Name
Total reverse shoulder prosthesis
Model / Reference
DWH541B
Primary DI / UDI-DI
03700386953002
510(k) Number
FDA Product Code
KWS, HSD, PHX
GMDN Term
Total reverse shoulder prosthesis
Device Class
Class II
Regulation Number
888.3660, 888.3690
GUDID distribution status
Not in Commercial Distribution
Size
Angle — 12.5 degree
Outer Diameter — 36 Millimeter

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