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AEQUALIS™ PerFORM Reversed DWJ625

by Tornier, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

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 Number00846832061082 UDI-DI Date21 Nov 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-1237-2026 FDA Class II initiated 19 Dec 2025

    A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.

    • Ongoing Z-0113-2024 FDA Class II initiated 15 Sep 2023

    One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.

    • Ongoing Z-1216-2022 FDA Class II initiated 3 May 2022 on shared 510(k) K161742

    The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.

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  • Withdrawn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™ PerFORM Reversed
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Reference
DWJ625
Primary DI / UDI-DI
00846832061082
FDA Product Code
PHX, KWS
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
Not in Commercial Distribution
Size
Outer Diameter — 9.5 Millimeter
Length — 25 Millimeter

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

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