Skip to content

Ratchet Handle 110017408

by Biomet Orthopedics, Inc.

Ref 110017408

Ratchet Handle 110017408 is a device classified as Class I in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI 889024AD7YB), cleared under FDA 510(k) K140891 on 3 Jun 2014 and listed in FDA GUDID since 23 Mar 2021 (UDI-DI 00887868466557), 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 MDR 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/MDR EUDAMED Number889024AD7YB Basic UDI-DI 00887868466557UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868466557 UDI-DI Date23 Mar 2021ListedStatusListed 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 889024AD7YB registered 31 Oct 2026 Active
  • FDA 510(k) K140891 decided 3 Jun 2014 Active
  • FDA GUDID UDI-DI 00887868466557 listed 23 Mar 2021 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 00887868466557
  8. Registered EUDAMED 889024AD7YB

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Ratchet Handle
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Biomet Ratcheting Straight Handle
Model / Ref / Catalog
110017408
Primary DI / UDI-DI
00887868466557
Basic UDI-DI
889024AD7YB
Direct marketing DI
00887868466557
510(k) Number
FDA product code
HWC
EMDN code
Z12021199 Orthopaedic endoscopy instruments - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K140891)

and 8 more cleared under K140891

Similar devices in this category

Other devices filed under ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)