Instrument, Cast Removal, Ac-powered
Orthopedic · 21 CFR 888.5960
Recent MDR events
108 adverse event reports on file
- CAST REMOVAL SAWFeb 20, 2026MalfunctionDerma Sciences, Inc.3005920706-2026-00008
- AMERICAN ORTHOPEDICSep 24, 2025MalfunctionBsn Medical, Inc.23132237
- DELTA-CAST SERENEJul 22, 2025InjuryBsn Medical Inc.1038963-2025-00002
- CAST REMOVAL SAW STAINLESS STEEL BLADESJul 16, 2025InjuryDerma Sciences, Inc.3005920706-2025-00016
- DELTA-CAST® SERENEApr 25, 2025InjuryBsn Medical Inc.1038963-2025-00001
- STRYKER 940 CAST SAWMar 26, 2025InjuryStryker Ireland Ltd., Instruments DivisionMW5168256
- AMERICAN ORTHOPAEDIC CAST CUTTER - HEX DRIVENov 25, 2024MalfunctionBsn Medical, Inc.20770986
- CAST REMOVAL SAWMay 24, 2024MalfunctionDerma Sciences, Inc.3005920706-2024-00004
- ION NITRIDED BLADENov 13, 2019MalfunctionStryker Instruments-kalamazoo0001811755-2019-03758
- ION NITRIDED BLADEJun 11, 2019MalfunctionStryker Instruments-kalamazoo0001811755-2019-01950
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
38 firms currently registered for this product code
Stryker Ireland Ltd., Instruments Division
CARRIGTWOHILL, CO.CORK Munster, IE
Prime Medica Promotion Private Limited
Vadodara Gujarat, IN
Narang Medical, Ltd.
New Delhi, IN
Bsn Medical, Inc.
CHARLOTTE, NC, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
Baeramed Instrumente Gmbh
SCHWENNINGEN Baden-Wurttemberg, DE
Cm Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Jiangsu Senolo Medical Technology Co., Ltd.
Yancheng Jiangsu, CN
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Oscimed Sa
LA CHAUX-DE-FONDS, NE Neuchatel, CH
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Cascade Orthopedic Supply, Lp.
Chico, CA, US
Sterramed Inc
Weehawken, NJ, US
Stryker Ireland Ltd. Instruments Division, Innovation Centre
Carrigtwohill Cork (County), IE
Auxein Medical Private Limited
Sonipat Haryana, IN
De Soutter Medical Ltd.
ASTON CLINTON Buckinghamshire, GB
Manman Manufacturing Company Private Limited
Pune Maharashtra, IN
Derma Sciences Canada, Inc (dba Derma Sciences, Inc.)
TORONTO Ontario, CA
Good Medica Sp.zo.o.
Wroclaw Dolnoslaskie, PL
Atlas Intl.
RANCHO CORDOVA, CA, US
Bsn Medical Inc.
Hickory, NC, US
Zepf Medical Instruments Gmbh
SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE
Prime Medical, Inc.
HWASEONG-SI Gyeonggi, KR
Med2b Ltd.
Kitzingen Bavaria, DE
510(k) clearances
9 clearances for this product code
- Carapace, Inc.Jan 28, 1994
K932653 · SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
- Buckman Co., Inc.Apr 23, 1990
K901677 · CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER
- Bremer Mfg. & Tool Co., Inc.Nov 16, 1989
K893380 · QCR SYSTEM I AND QCR SYSTEM II
- Johnson & Johnson Professionals, Inc.Oct 19, 1989
K895861 · DELTA-TECH(TM) CAST REMOVAL SYSTEM
- Martin MedicalDec 10, 1987
K873723 · PLASTER VACUUM, 230V MODEL NO. 4183-161
- Martin MedicalDec 7, 1987
K873721 · PLASTER VACUUM, 115V MODEL NO. 4183-160
- Martin MedicalOct 2, 1987
K873719 · CAST CUTTER, 115V MODEL NO. 4183-106
- Martin MedicalOct 2, 1987
K873720 · CAST CUTTER, 230V MODEL NO. 4183-107