Evacuator, Vapor, Cement Monomer
Orthopedic · 21 CFR 888.4220
Recent MDR events
19 adverse event reports on file
- CARTRIDGE KITJun 27, 2025MalfunctionZimmer Surgical, Inc.0001526350-2025-00811
- FRONT LOADING CARTRIDGE KIT COMPATIBLE WITH VACUUM MIXING SYSTEMJun 26, 2025MalfunctionZimmer Surgical, Inc.0001526350-2025-00808
- MILLER BONE CEMENT INJECTORMay 7, 2024MalfunctionZimmer Biomet, Inc.0001822565-2024-01503
- MILLER BONE CEMENT INJECTORMay 7, 2024MalfunctionZimmer Biomet, Inc.0001822565-2024-01504
- FRONT LOADING CARTRIDGE KITSep 18, 2023MalfunctionZimmer Biomet, Inc.0001822565-2023-02534
- FRONT LOADING CARTRIDGE KITMay 5, 2022MalfunctionZimmer Biomet, Inc.0001822565-2022-01253
- MORELANDFeb 22, 2019MalfunctionDepuy Orthopaedics, Inc.8361200
- NOT COMMUNICATEDFeb 21, 2019MalfunctionBiomet France S.a.r.l.3006946279-2019-00109
- FRONT LOADING CARTRIDGE KIT VACUUM MIXING SYSTEMApr 20, 2018MalfunctionZimmer Surgical, Inc.0001526350-2018-00332
- FRONT LOADING CARTRIDGE KITNov 8, 2017MalfunctionZimmer Surgical, Inc.0001526350-2017-00833
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
22 firms currently registered for this product code
Scitek Global Co.,ltd
Jinan Shandong, CN
Infitek Co., Ltd.
Shanghai, CN
Summit Medical Ltd.
GLOUCESTERSHIRE, GB
Osartis Gmbh
Muenster Hesse, DE
Mctbio
Yongin-si Gyeonggi, KR
Depuy (ireland)
CO. CORK Munster, IE
Medacta International Sa
Castel San Pietro Ticino, CH
Smith & Nephew, Inc.
MEMPHIS, TN, US
Smith & Nephew, Inc.
Memphis, TN, US
Labpeak Co.,ltd
Jinan Shandong, CN
Smith & Nephew, Inc.
Memphis, TN, US
Depuy Orthopaedics, Inc.
WARSAW, IN, US
Heraeus Medical Llc
Yardley, PA, US
Sterigenics Us, Llc
Lewis Center, OH, US
Zimmer Surgical, Inc.
Dover, OH, US
Heraeus Medical Gmbh
WEHRHEIM Hesse, DE
Medacta International Sa
Rancate Ticino, CH
Biomet, Inc.
WARSAW, IN, US
Auxein Medical Private Limited
Sonipat Haryana, IN
Depuy Cmw
BLACKPOOL, LANCASHIRE, GB
Zimmer, Inc.
WARSAW, IN, US
Depuy Intl., Ltd.
LEEDS, GB
510(k) clearances
8 clearances for this product code
- Arbor Technologies, Inc.Jan 4, 1991
K902167 · CONTAIN(TM) LASER PLUME FILTER
- Hollister, Inc.Oct 30, 1990
K902056 · LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER
- Lifestream Int'L, Inc.Jul 23, 1986
K862509 · CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000
- Walgen Medical InnoventionsMar 13, 1981
K810542 · CEMENT FUME EVACUATOR TANK & FILTER
- Stackhouse Assoc.May 23, 1979
K790877 · BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO
- Medishield, Inc.Feb 21, 1978
K780202 · MONOMER EVACUATION SYSTEM
- Howmedica Corp.Jul 21, 1977
K770690 · MASK, VAPOR, MONOMER
- Howmedica Corp.Nov 11, 1976
K760906 · MONOMER VAPOR CONTAINMENT SYSTEM