Skip to content

G7 Provisional High Wall Liner 010002647

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304565821 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not in commercial distribution

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
G7 Provisional High Wall Liner
Generic Name
Acetabulum prosthesis trial, prefabricated, reusable
Model / Ref / Catalog
010002647
Primary DI / UDI-DI
00880304565821
510(k) Number
FDA Product Code
JDI, PBI, OQH, LZO, OQI, OQG, LPH, LWZ, KWZ
GMDN Term
Acetabulum prosthesis trial, prefabricated, reusable
Device Class
Class II
Regulation Number
888.3350, 888.3310, 888.3353, 888.3358
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K121874)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No