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Ultra-Drive Tool 423828

by Biomet Orthopedics, Inc.

Ultra-Drive Tool 423828 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K031280 on 22 Sep 2003 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 00880304372887), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K031280

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304372887 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK031280 Date22 Sep 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031280 decided 22 Sep 2003 Active
  • FDA GUDID UDI-DI 00880304372887 listed 3 Oct 2016 Listed

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1963-2019 FDA Class II initiated 4 Jun 2019 on shared 510(k) K031280
    • Terminated Z-1962-2019 FDA Class II initiated 4 Jun 2019 on shared 510(k) K031280

    The products do not have sufficient data to support the labeled shelf life of 10 years.

    • Terminated Z-1521-2012 FDA Not yet classified initiated 18 Apr 2012

    Incorrect product picture label was on the product box.

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K031280
  2. Recall initiated FDA recalls Z-1521-2012
  3. Listed FDA GUDID 00880304372887
  4. Recall initiated FDA recalls Z-1963-2019
  5. Recall initiated FDA recalls Z-1962-2019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ultra-Drive Tool
Generic name
Hard-tissue ultrasonic surgical system handpiece tip
Model / Ref / Catalog
423828
Primary DI / UDI-DI
00880304372887
510(k) Number
FDA product code
JXE
GMDN term
Hard-tissue ultrasonic surgical system handpiece tip
Device class
Class II
Regulation number
882.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hard-tissue ultrasonic surgical system handpiece tip

Cleared under the same submission (K031280)

and 8 more cleared under K031280

Similar devices

Other devices filed under FDA product code JXE (Device, Nerve Conduction Velocity Measurement).

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)