Skip to content

Cannulated Screw 110009847

by Biomet Orthopedics, Inc.

Ref 110009847

Cannulated Screw 110009847 is a device classified as Class IIb 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-00887868463884), cleared under FDA 510(k) K140891 on 3 Jun 2014 and listed in FDA GUDID since 23 Mar 2021 (UDI-DI 00887868463884), 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-00887868463884 Basic UDI-DI 00887868463884UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868463884 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 B-00887868463884 registered 23 Oct 2026 Active
  • FDA 510(k) K140891 decided 3 Jun 2014 Active
  • FDA GUDID UDI-DI 00887868463884 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 00887868463884
  8. Registered EUDAMED B-00887868463884

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
Cannulated Screw
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
MFA_4 0 Biomet Cannulated Screws_Fully Threaded ST
Model / Ref / Catalog
110009847
Primary DI / UDI-DI
00887868463884
Basic UDI-DI
B-00887868463884
510(k) Number
FDA product code
HWC
EMDN code
P09120603 Cannulated screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class IIb 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
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb 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 bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K140891)

and 8 more cleared under K140891

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)