Blade, Saw, Surgical, Cardiovascular
General, Plastic Surgery · 21 CFR 878.4820
Recent MDR events
159 adverse event reports on file
- Sternum Blade, Offset (31.5 x 0.64 x 6.2mm)Jul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99416
- STERNUM BLADE, OFFSET (31.5 X 0.64 X 6.2MM)Apr 21, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00721
- STERNUM BLADEJan 22, 2024MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2024-00112
- STRYKER PERFORMANCE SERIES STERNUM BLADE(30.5 X 1MM)Jan 22, 2024MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2024-00212
- STERNUM BLADE (100PK) OFFSET (32.0 X 0.79 X 6.3MM)Jan 13, 2023InjuryStryker Instruments-a Division Of Stryker Corp3015967359-2023-00054
- STERNUM BLADE (100PK) OFFSET (32.0 X 0.79 X 6.3MM)Jan 13, 2023MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2023-00055
- STERNUM BLADENov 4, 2022MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2022-02242
- STERNUM BLADESep 27, 2022MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2022-01829
- STERNUM BLADE, OFFSET (31.7 X 0.64 X 6.3MM)Sep 6, 2022MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2022-01748
- STERNUM BLADE, OFFSET (31.7 X 0.64 X 6.3MM)Sep 6, 2022MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2022-01746
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
37 firms currently registered for this product code
Stryker Instruments
Portage, MI, US
Precision Edge Surgical Products Company
Sault Sainte Marie, MI, US
Medtronic Powered Surgical Solutions
FORT WORTH, TX, US
Bien-air Surgery Sa
Le Noirmont Jura, CH
Aesculap, Inc.
CENTER VALLEY, PA, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Deroyal Industries, Inc.
POWELL, TN, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Aspen Surgical Products, Inc.
Caledonia, MI, US
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Surgicrafts
Sialkot Punjab, PK
Xinhua Surgical Instrument Co. Ltd.
ZIBO Shandong, CN
Garish Apparels
Wazirabad Punjab, PK
Wexler Surgical, Inc.
HOUSTON, TX, US
Applimed Sa -cssr
Châtel St Denis Fribourg, CH
Stryker Ireland Ltd., Instruments Division
CARRIGTWOHILL, CO.CORK Munster, IE
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
Synergy Health Westport Ltd
Westport Mayo, IE
Millennium Surgical Corp
Schaumburg, IL, US
Cbr Enterprise Limited
Hong Kong, HK
Ad Supply Group Limited
London London, City of, GB
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Brasseler U.s.a. Medical, Llc
Savannah, GA, US
Med2b Ltd.
Kitzingen Bavaria, DE
510(k) clearances
4 clearances for this product code
- Codman & Shurtleff, Inc.Nov 21, 1990
K904352 · CODMAN COLLINS RADIOPARENT STERNAL BLADES
- Hall Surgical, Division of Zimmer, Inc.Jul 17, 1986
K862474 · HALL STERNUM SAW
- Micro-Aire Surgical Instruments, Inc.Mar 1, 1985
K850483 · MICRO-AIRE STERNUM SAW REPLACEMENT BLADES
- Temp Medical Products, Inc.Mar 24, 1983
K830189 · CARDIOVASCULAR SAW BLADES