Cutter, Surgical
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
607 adverse event reports on file
- CORDCUTTER EAJul 10, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02996
- CORDCUTTERJul 8, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02935
- CORDCUTTERJun 30, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02853
- CORDCUTTER *EAJun 1, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02352
- CORDCUTTER *EAMay 26, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02162
- ARTHRO SUTURE SCISSORSMay 19, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02101
- CORDCUTTER EAApr 21, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-01594
- CORDCUTTER EAApr 21, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-01595
- TABLE TOP ROD CUTTER AND BENDERApr 20, 2026MalfunctionSynthes Gmbh8030965-2026-03610
- NAMar 25, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-01225
Event type breakdown
Recalls
6 recall events for this product code
- Sklar InstrumentsOpen, ClassifiedJan 16, 2025
ECONO STERILE medical procedure kits labeled as:
Reports of various packaging issues that may result in a breach of the sterile barrier.
Z-0932-2025 · View FDA record ↗ - Maquet CardiovascularTerminatedFeb 11, 2011
Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey.
Pouch integrity may be compromised, resulting in loss of sterility.
Z-1222-2011 · View FDA record ↗ - Ethicon Endo-Surgery IncTerminatedAug 25, 2008
ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Z-2161-2008 · View FDA record ↗ - Ethicon Endo-Surgery IncTerminatedAug 25, 2008
ENDOPATHETS Endoscopic Linear Cutter, TSW35.
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Z-2162-2008 · View FDA record ↗ - Ethicon Endo-Surgery IncTerminatedAug 25, 2008
ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W.
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Z-2163-2008 · View FDA record ↗ - Ethicon Endo-Surgery IncTerminatedAug 25, 2008
FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S.
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Z-2164-2008 · View FDA record ↗
Registered firms
256 firms currently registered for this product code
Sterigenics U.s., Llc
Corona, CA, US
Oertel Medical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Aesculap Chifa Sp. Z O.o.
NOWY TOMYSL Wielkopolskie, PL
Ortho-med, Inc.
Tigard, OR, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Darleys Surgical Co.
SIALKOT, PUNJAB, PK
Miraclus Orthotech Private Limited
Ahmedabad Gujarat, IN
Vericel Corporation
CAMBRIDGE, MA, US
Jay-med
SIALKOT Punjab, PK
Isomedix Operations Inc.
WHIPPANY, NJ, US
Rti Surgical, Inc. (dba Rti Biologics, Inc.)
ALACHUA, FL, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Zimmer Gmbh
WINTERTHUR Zurich, CH
Med Saver, Inc.
PHOENIXVILLE, PA, US
Cm Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Cardinal Health 200, Llc
Waukegan, IL, US
Robinson Healthcare Limited
Worksop Nottinghamshire, GB
Med2b Ltd.
Kitzingen Bavaria, DE
Andersen Caledonia Ltd
Bellshill Scotland, GB
Jai Surgicals Ltd.
ALWAR Rajasthan, IN
Jabil Inc. (monument)
Monument, CO, US
Mectalent Ltd.
Oulu Kainuu, FI
Garish Apparels
Wazirabad Punjab, PK
Bioplate, Inc.
Placentia, CA, US
Avilign Medical
Sialkot Punjab, PK
510(k) clearances
52 clearances for this product code
- Nuscience Consulting and Management Group, LLCSep 12, 2011
K112400 · SMARTSHEARS
- United States Surgical, A Division of Tyco HealthcMay 4, 1989
K890818 · AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
- Micrins Surgical, Inc.Aug 17, 1987
K872990 · MICRINS SURGICAL SCISSOR
- Paris Products, Inc.Jul 23, 1984
K841741 · SINGLE HAIR TRANSPLANT GRAFT
- Surgical Products Corp.May 2, 1984
K841247 · SPC DISPOSABLE CUTTER
- J. Sklar Mfg. Co., Inc.Sep 14, 1982
K822448 · SCISSORS, VARIOUS
- Fred Sammons, Inc.Jun 24, 1982
K821632 · SURGICAL SCISSORS, SET OF 3
- Conphar, Inc.May 27, 1982
K821355 · CONPHAR LITTAUER SCISSORS