Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive
Orthopedic · 21 CFR 888.3310
For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Recent MDR events
2,276 adverse event reports on file
- G7 ACETABULAR LINERJul 20, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02146
- G7 CURVED INSERTER THD SHAFTJul 16, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02090
- G7 CURVED INSERTER THD SHAFTJul 15, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02072
- G7 NEUTRAL E1 LINER 40MM GJul 15, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02076
- G7 VIT E FRDM CONST LNR 36MM EJul 14, 2026MalfunctionZimmer Biomet, Inc.0001822565-2026-02571
- G7 FREEDOM CONST E1 LNR 36MM GJul 9, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02033
- G7 SCREW 6.5MM X 30MMJul 8, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02002
- G7 SCREW 6.5MM X 15MMJul 8, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02003
- G7Jul 8, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02020
- G7 PPS LTD ACET SHELL 54FJul 1, 2026InjuryZimmer Biomet, Inc.0001825034-2026-01944
Event type breakdown
Recalls
2 recall events for this product code
- Biomet, Inc.TerminatedJun 19, 2014
G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
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.
Z-1837-2014 · View FDA record ↗ - Biomet, Inc.TerminatedJun 19, 2014
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
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.
Z-1838-2014 · View FDA record ↗
Registered firms
94 firms currently registered for this product code
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Isomedix Operations, Inc.
Libertyville, IL, US
Zimmer Biomet G.k.
Hiratsuka Kanagawa, JP
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Biomet, Inc.
WARSAW, IN, US
Sterigenics Us, Llc
Lewis Center, OH, US
Zhejiang Biomet Medical Products Co., Ltd.
Jinhua Zhejiang, CN
Zimmer Pte. Ltd.
Singapore South East, SG
Synergy Health Sterilisation Uk Ltd
Daventry Northamptonshire, GB
Sterigenics Us Llc
Gurnee, IL, US
Donson Machine Company
ALSIP, IL, US
Synergy Health Sterilisation Uk Ltd
Berkshire Reading, GB
Changzhou Biomet Medical Devices Co., Ltd.
Changzhou City Jiangsu, CN
Shanghai Jpy Ion-tech Co., Ltd.
SHANGHAI, CN
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Single Source Medical Llc
Churubusco, IN, US
Medical Conteneur Sas
SAINT-SOUPPLETS Seine-et-Marne, FR
510(k) clearances
2 clearances for this product code