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05.001.025

by Synthes

05.001.025 (05001025) is a Class II device made by Synthes, cleared under FDA 510(k) K043310 on 5 Jan 2005 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 10886982128362), active as of 23 Oct 2026. 6 FDA recalls are 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

6 closed

Documents

510(k) K043310

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 Number10886982128362 UDI-DI Date30 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK043310 Date5 Jan 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043310 decided 5 Jan 2005 Active
  • FDA GUDID UDI-DI 10886982128362 listed 30 Jun 2016 Listed

Recalls

6 recalls · FDA

    • Terminated Z-0681-2017 FDA Class II initiated 1 Nov 2016

    Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

  • 2 recalls, same reason

    • Terminated Z-2784-2016 FDA Class I initiated 24 Jun 2016
    • Terminated Z-2783-2016 FDA Class I initiated 24 Jun 2016

    There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.

    • Terminated Z-2199-2016 FDA Class II initiated 31 May 2016

    DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.

    • Terminated Z-1313-2015 FDA Class II initiated 19 Dec 2014

    In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.

    • Terminated Z-0615-2014 FDA Class II initiated 15 Apr 2013

    Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.

Timeline

8 dated events

  1. Cleared FDA 510(k) K043310
  2. Recall initiated FDA recalls Z-0615-2014
  3. Recall initiated FDA recalls Z-1313-2015
  4. Recall initiated FDA recalls Z-2199-2016
  5. Recall initiated FDA recalls Z-2784-2016
  6. Recall initiated FDA recalls Z-2783-2016
  7. Listed FDA GUDID 10886982128362
  8. Recall initiated FDA recalls Z-0681-2017

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Bone/joint surgical power tool motor, electric
Model / Ref / Catalog
05.001.025, 05001025
Primary DI / UDI-DI
10886982128362
510(k) Number
FDA product code
ERL, HBE, DZI, HWE
GMDN term
Bone/joint surgical power tool motor, electric
Device class
Class II
Regulation number
874.4250, 882.4310, 872.4120, 878.4820
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone/joint surgical power tool motor, electric

Cleared under the same submission (K043310)

and 8 more cleared under K043310

Similar devices in this category

Other devices filed under Bone/joint surgical power tool motor, electric.

Other devices from Synthes

  • 68.134.011

    Class II

  • Volt 68.134.111

    Class II

  • Volt 68.134.200

    Class II

  • 68.045.017

    Class II

See all devices from Synthes →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)