LZVClass II
System, Cement Removal Extraction
Orthopedic · 21 CFR 888.4580
MDR events21All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances7All time
Recent MDR events
21 adverse event reports on file
- OSCAROct 31, 2018MalfunctionOrthofix Srl2183449-2018-00032
- OSCAR 3Jan 20, 2017MalfunctionOrthofix Inc.6266006
- INTERCONDYLAR FEMORAL CHISELMay 1, 2008MalfunctionDepuy Orthopaedics, Inc.1040872
- ULTRA DRIVEJul 20, 2007InjuryBiomet OrthopedicsMW5003141
- ULTRA - DRIVE DISK DRILLJan 12, 2007OtherBiomet, Inc.1825034-2007-00011
- BIOMET 9.5 MM DISK DRILL TIPDec 5, 2006OtherBiomet. Inc.MW1041261
- RENOVATIONNov 13, 2006InjurySmith & Nephew, Inc., Orthopaedic Div1020279-2006-00642
- *Aug 14, 2006Malfunction*MW1040067
- SMITH NEPHEW RICHARDMar 9, 2005MalfunctionSmith Nephew RichardMW1034900
- ULTRA - DRIVE DISK DRILLFeb 23, 2005OtherBiomet, Inc.1825034-2005-00016
Event type breakdown
Malfunction10
Injury7
Other4
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Orthosonics, Ltd.Jun 6, 2002
K021502 · OSCAR, MODEL OE3000
- Stryker Corp.Jul 15, 1996
K961101 · STRYKER CEMENT REMOVAL SYSTEM
- Sonokinetics, Inc.Jan 21, 1994
K930629 · ACRYL-X II SYSTEM
- Origin Medsystems, Inc.Nov 27, 1990
K904156 · ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS
- Origin Medsystems, Inc.Nov 20, 1990
K904180 · PROSTHETIC CEMENT REMOVER
- Implant Technology, Inc.May 2, 1989
K891472 · IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
- Albert K. ChinApr 19, 1989
K890285 · PROSTHETIC CEMENT REMOVER