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G7 010002454

by Biomet Orthopedics, Inc.

G7 010002454 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K121874 on 23 Nov 2012 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00880304564510), active as of 23 Oct 2026. 3 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

1 ongoing

This device is named in the recall

Documents

510(k) K121874

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 Number00880304564510 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121874 Date23 Nov 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121874 decided 23 Nov 2012 Active
  • FDA GUDID UDI-DI 00880304564510 listed 21 Sep 2016 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

5 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 00880304564510
  5. Recall initiated FDA recalls Z-0007-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
G7
Generic name
Acetabulum prosthesis trial, prefabricated, reusable
Model / Ref / Catalog
010002454
Primary DI / UDI-DI
00880304564510
510(k) Number
FDA product code
OQI, OQH, JDI, LPH, PBI, LZO, OQG, LWZ, KWZ
GMDN term
Acetabulum prosthesis trial, prefabricated, reusable
Device class
Class II
Regulation number
888.3353, 888.3350, 888.3358, 888.3310
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Acetabulum prosthesis trial, prefabricated, reusable

Cleared under the same submission (K121874)

and 8 more cleared under K121874

Similar devices in this category

Other devices filed under Acetabulum prosthesis trial, prefabricated, reusable.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

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