Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer
Orthopedic · 21 CFR 888.3560
Recent MDR events
163 adverse event reports on file
- BIOMET STEMMED TIBIAL TRAY 71MMJun 5, 2026InjuryZimmer Biomet, Inc.0001825034-2026-01629
- BIOMET ILOK PRI TIB TRAY 79MMJun 10, 2024InjuryZimmer Biomet, Inc.0001825034-2024-01534
- VANGUARD 360 DST FM AG 60X5 RL/LMMay 16, 2024InjuryZimmer Biomet, Inc.0001825034-2024-01261
- VANGUARD 360 DST FM AG 60X10 LL/RMMay 16, 2024InjuryZimmer Biomet, Inc.0001825034-2024-01260
- UNKNOWN TRICON M RECON KNEE IMPLANTOct 23, 2023InjurySmith & Nephew, Inc.1020279-2023-02022
- UNKNOWN TRICON M RECON KNEE IMPLANTOct 23, 2023InjurySmith & Nephew, Inc.1020279-2023-02024
- UNKNOWN TRICON LL RECON KNEE IMPLANTOct 22, 2023InjurySmith & Nephew, Inc.1020279-2023-02010
- UNKNOWN TRICON LL RECON KNEE IMPLANTOct 22, 2023InjurySmith & Nephew, Inc.1020279-2023-02012
- UNKNOWN TRICON LL RECON KNEE IMPLANTOct 22, 2023InjurySmith & Nephew, Inc.1020279-2023-02013
- UNKNOWN TRICON M RECON KNEE IMPLANTOct 22, 2023InjurySmith & Nephew, Inc.1020279-2023-02016
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
84 firms currently registered for this product code
Zimmer Biomet G.k.
Hiratsuka Kanagawa, JP
Biomet, Inc.
WARSAW, IN, US
Zhejiang Biomet Medical Products Co., Ltd.
Jinhua Zhejiang, CN
Sterigenics Us Llc
Gurnee, IL, US
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Zimmer Pte. Ltd.
Singapore South East, SG
Sterigenics Us, Llc
Lewis Center, OH, US
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Zimmer Biomet Canada Dfe
Mississauga Ontario, CA
Sheffield Precision Medical Ltd
Sheffield, GB
Zimmer, Inc.
WARSAW, IN, US
Synergy Health Sterilisation Uk Ltd
Berkshire Reading, GB
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Isomedix Operations, Inc.
Libertyville, IL, US
Zimmer Biomet Korea Ltd.
Seoul, KR
Changzhou Biomet Medical Devices Co., Ltd.
Changzhou City Jiangsu, CN
Paragon Medical Device (changzhou) Co., Ltd.
Changzhou Jiangsu, CN
Single Source Medical Llc
Churubusco, IN, US
510(k) clearances
14 clearances for this product code
- Biomet, Inc.Feb 14, 2001
K010212 · OFFSET TIBIAL TRAY
- Richards Medical Co., Inc.Nov 21, 1989
K884824 · TRICON-M TOTAL KNEE SYSTEM
- Protek, Inc.Oct 28, 1987
K873429 · FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE
- Protek, Inc.Feb 18, 1986
K853730 · FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
- Richards Medical Co., Inc.Nov 29, 1983
K833200 · TRICON M TOTAL KNEE SYSTEM
- Depuy, Inc.Sep 1, 1983
K831441 · POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
- Advanced Biosearch Assn.Aug 16, 1983
K832302 · MARK I TOTAL KNEE SYS. ARTHROPLASTY
- Advanced Biosearch Assn.Jun 22, 1983
K830726 · MARK I & II TOTAL KNEE REPLACE. SYS