Chisel (osteotome)
General, Plastic Surgery · 21 CFR 878.4820
Recent MDR events
16 adverse event reports on file
- RD INSTRUMENT INTRADISCALApr 22, 2024MalfunctionMedtronic Sofamor Danek Usa, Inc1030489-2024-00306
- UNKN ORTHOPAEDIC RECONSTRUCTION DEVNov 26, 2021InjurySmith & Nephew, Inc.1020279-2021-08421
- KONIG 9" (22.9 CM) STRAIGHT LAMBOTTE OSTEOTOME WITH 6 MM BLADEOct 14, 2020MalfunctionMedline Industries, Inc.10676807
- BOXED CHISELDec 10, 2014MalfunctionZimmer Gmbh9613350-2014-04184
- BOXED CHISELOct 15, 2014OtherZimmer Gmbh9613350-2014-03992
- LEXER CHISEL 8.0/ 1.280Nov 12, 2013OtherZimmer Gmbh9613350-2013-02030
- DEVICE ONE: CERVICAL INSTRUMENT CHISEL, 7MMApr 22, 2013InjuryGlobus Medical, Inc.3004142400-2013-00004
- OSTEOTOMEJul 24, 2012Malfunction1226348-2012-00356
- BOX CHISELAug 19, 2010InjuryStryker Orthopaedics Mahwah2249697-2010-01116
- BOX CHISELDec 8, 2008MalfunctionStryker Orthopaedics Mahwah2249697-2008-00387
Event type breakdown
Recalls
14 recall events for this product code
- AAP Implantate AgTerminatedUnknown
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Z-1019-2019 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
Normed Charcot Osteotome Chisel (Various sizes)
Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
Z-1360-2018 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
Z-1909-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
Z-1910-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
Z-1911-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
Z-1912-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
Z-1913-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
Z-1914-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
Z-1915-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
Z-1916-2017 · View FDA record ↗
Registered firms
88 firms currently registered for this product code
Phoenix Instruments, Inc.
Lisle, IL, US
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Scanlan International, Inc.
Saint Paul, MN, US
Qsa Surgical (pvt) Ltd.
SIALKOT Punjab, PK
T.a. Walthem & Company
SIALKOT PUNJAB, PK
Fetzer Surgical, Llc
Scottsdale, AZ, US
Rsb Spine Llc.
Wooster, OH, US
J & J Instruments, Llc
Stratford, CT, US
Amnotec International Medical Gmbh
Neuhausen ob Eck Baden-Wurttemberg, DE
Anmuth Medical International Llc
Beverly, MA, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Medline Renewal
Redmond, OR, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Fischer Surgical Inc.
Imperial, MO, US
Post Surgical Mfg.
Hauppauge, NY, US
Fujita Medical Instruments Co., Ltd
Tokyo, JP
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Instrumed International Inc Dba Avalign German Specialty Instruments
SCHAUMBURG, IL, US
E A Beck & Co
Schaumburg, IL, US
Microaire Surgical Instruments Llc
CHARLOTTESVILLE, VA, US
Schobell Industrial Ltda
Rio Claro Sao Paulo, BR
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Princeton Medical Group, Inc.
Franklin, TN, US
Ldr Medical
Sainte-Savine Aube, FR
Mclean Medical & Scientific
Saint Paul, MN, US
510(k) clearances
11 clearances for this product code
- Avail-Southwest DivisionJul 10, 1995
K952678 · STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT
- Waterstone Medical, Inc.Jun 29, 1995
K952200 · OMNI-JUG
- Fdt Precision Machine Co., Inc.Aug 18, 1989
K894785 · SURGICAL CHISEL/OSTEOTOME
- Sil-Med Corp.Aug 15, 1989
K891471 · SIL-MED WASTE FLUID DUMP BAG
- Porex MedicalAug 21, 1987
K872947 · POREX QUALITY PLASTIC SURGERY INSTRUMENTS
- Military Engineering, Inc.Jun 23, 1987
K872092 · OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5
- Cher Mel Corp.Aug 2, 1984
K842824 · CHERMEL BONE CHISELS
- Edward Weck, Inc.Mar 9, 1978
K772373 · ANDERSON-NEIVERT OSTEOTOME