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Solid Hexalobular Driver AO 110009963

by Biomet Orthopedics, Inc.

Ref 110009963

Solid Hexalobular Driver AO 110009963 is a device classified as Class IIa in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-00887868522789), cleared under FDA 510(k) K140891 on 3 Jun 2014 and listed in FDA GUDID since 19 Dec 2020 (UDI-DI 00887868522789), active as of 7 Nov 2026. 5 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140891

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868522789 Basic UDI-DI 00887868522789UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868522789 UDI-DI Date19 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140891 Date3 Jun 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00887868522789 registered 23 Oct 2026 Active
  • FDA 510(k) K140891 decided 3 Jun 2014 Active
  • FDA GUDID UDI-DI 00887868522789 listed 19 Dec 2020 Listed

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0617-2021 FDA Class II initiated 25 Nov 2020
    • Terminated Z-0618-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

  • 2 recalls, same reason

    • Terminated Z-2304-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2303-2020 FDA Class II initiated 14 May 2020

    Distributed to the field without having completed design history files or design transfer activities

    • Terminated Z-1064-2018 FDA Class II initiated 7 Dec 2017

    One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

Timeline

8 dated events

  1. Cleared FDA 510(k) K140891
  2. Recall initiated FDA recalls Z-1064-2018
  3. Recall initiated FDA recalls Z-2304-2020
  4. Recall initiated FDA recalls Z-2303-2020
  5. Recall initiated FDA recalls Z-0617-2021
  6. Recall initiated FDA recalls Z-0618-2021
  7. Listed FDA GUDID 00887868522789
  8. Registered EUDAMED B-00887868522789

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Solid Hexalobular Driver AO
Generic name
Orthopaedic implant driver
Model / Ref / Catalog
110009963
Primary DI / UDI-DI
00887868522789
Basic UDI-DI
B-00887868522789
510(k) Number
FDA product code
HWC
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Orthopaedic implant driver
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic implant driver

Cleared under the same submission (K140891)

and 8 more cleared under K140891

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)