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G7® 110003455

by Biomet Orthopedics, Inc.

Ref 110003455

G7® 110003455 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 B-00887868462535), cleared under FDA 510(k) K121874 on 23 Nov 2012 and listed in FDA GUDID since 30 Apr 2021 (UDI-DI 00887868462535), active as of 7 Nov 2026. 3 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121874

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-00887868462535 Basic UDI-DI 00887868462535UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868462535 UDI-DI Date30 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121874 Date23 Nov 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00887868462535 registered 31 Oct 2026 Active
  • FDA 510(k) K121874 decided 23 Nov 2012 Active
  • FDA GUDID UDI-DI 00887868462535 listed 30 Apr 2021 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0007-2023 FDA Class II initiated 25 Aug 2022

    The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

  • 2 recalls, same reason

    • Terminated Z-1837-2014 FDA Class II initiated 7 May 2014
    • Terminated Z-1838-2014 FDA Class II initiated 7 May 2014

    Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

Timeline

6 dated events

  1. Cleared FDA 510(k) K121874
  2. Recall initiated FDA recalls Z-1837-2014
  3. Recall initiated FDA recalls Z-1838-2014
  4. Listed FDA GUDID 00887868462535
  5. Recall initiated FDA recalls Z-0007-2023
  6. Registered EUDAMED B-00887868462535

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
G7®
Generic name
Orthopaedic implant aiming/guiding block, reusable
Device name
G7 Positioning Guide
Model / Ref / Catalog
110003455
Primary DI / UDI-DI
00887868462535
Basic UDI-DI
B-00887868462535
510(k) Number
FDA product code
LZO, LWZ, OQH, PBI, LPH, KWZ, OQG, JDI, OQI
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Orthopaedic implant aiming/guiding block, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3350, 888.3310, 888.3358
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 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: Orthopaedic implant aiming/guiding block, reusable

Cleared under the same submission (K121874)

and 8 more cleared under K121874

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

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