HBSClass I
Instrument, Clip Forming/cutting
Neurology · 21 CFR 882.4190
MDR events18All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances0All time
Recent MDR events
18 adverse event reports on file
- 1.55MM X 10MM TWIST DR,SMay 26, 2023MalfunctionDepuy Synthes Products Llc1045834-2023-00820
- EMAX 2 PLUS MOTORJun 22, 2022MalfunctionDepuy Synthes Products Llc1045834-2022-00740
- 7.5CM LARGE CRANIOTOME ATTCHApr 29, 2022MalfunctionDepuy Synthes Products Llc1045834-2022-00526
- HIGH SPEED ELEC G1 HANDPIECE AIR COOLEDApr 7, 2022MalfunctionDepuy Synthes Products Llc1045834-2022-00418
- HIGH SPEED ELEC G1 HANDPIECE AIR COOLEDFeb 24, 2022MalfunctionDepuy Synthes Products Llc1045834-2022-00210
- LAG SCREW DRILL SLEEVEMay 27, 2020InjurySmith & Nephew, Inc.1020279-2020-01870
- 2.8MM TAP DRILLDec 15, 2015InjuryAcumed Llc3025141-2015-00214
- ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIESMar 18, 2014InjurySynthes (usa)2520274-2014-10330
- FEMORAL NAILMay 3, 2007InjurySmith & Nephew, Inc., Orthopaedic Div.1020279-2007-00109
- CD HORIZON SPINAL SYSTEMJan 19, 2007MalfunctionWarsaw Orthopedic Inc.1030489-2007-00017
Event type breakdown
Injury8
Malfunction8
Unspecified2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.