Instrument, Ligature Passing And Knot Tying
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
635 adverse event reports on file
- IDEALJul 28, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03345
- IDEALJul 28, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03346
- IDEALJul 17, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03157
- IDEALJul 16, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03134
- IDEALJul 15, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03101
- IDEALJul 9, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02975
- SUTURE PASSOR PROJul 6, 2026MalfunctionThe O R Company Pty Ltd25716105
- IDEALJun 30, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02813
- IDEALJun 12, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02542
- IDEALJun 9, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-02465
Event type breakdown
Recalls
5 recall events for this product code
- Aesculap IncOpen, ClassifiedJan 31, 2024
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
Z-0866-2024 · View FDA record ↗ - Aesculap IncOpen, ClassifiedJan 31, 2024
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
Z-0867-2024 · View FDA record ↗ - New Wave Endo-Surgical, Corp.TerminatedMay 9, 2023
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
The plastic housing on the device may fracture
Z-1570-2023 · View FDA record ↗ - Teleflex MedicalTerminatedUnknown
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
The devices wings may become partially detached from the EFx Shield during use.
Z-0759-2017 · View FDA record ↗ - Teleflex MedicalTerminatedUnknown
Weck EFx Classic Fascial Closure System, Rx Only, Sterile,
Incorrect expiration date was printed on the product label.
Z-2538-2016 · View FDA record ↗
Registered firms
183 firms currently registered for this product code
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Hexamed Pvt Ltd
Sialkot Punjab, PK
Avalign Delivery Systems Division
Greenwood, IN, US
Ionisos
Dagneux Ain, FR
Endomed, Llc
Orlando, FL, US
Classic Wire Cut Company, Inc.
Valencia, CA, US
Surgix Medical Llc
Spring, TX, US
Dtr Medical Ltd
Swansea, GB
Trokamed Gmbh
GEISINGEN Baden-Wurttemberg, DE
Synthes (usa) Products Llc
West Chester, PA, US
Lockdown Medical Limited
Redditch Worcestershire, GB
Hazel Enterprises
Sialkot Punjab, PK
Cook Incorporated
Bloomington, IN, US
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Platinum Focus Group Ltd.
London London, City of, GB
Teleflex Llc (nadc)
Olive Branch, MS, US
Arvato Se
Hamburg, DE
Auckland Medical Technology (sichuan) Co. Ltd
Luzhou Sichuan, CN
Acheron Instruments (pvt.) Ltd.
LAHORE Punjab, PK
Surgipros Llc
Palmetto, FL, US
Integra Canada Ulc
Oakville Ontario, CA
Andersen Caledonia Ltd
Bellshill Scotland, GB
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Asanus Medizintechnik Gmbh
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Wexler Surgical, Inc.
HOUSTON, TX, US
510(k) clearances
5 clearances for this product code
- Edwards Lifesciences, LLCJun 16, 2015
K150882 · Edwards Suture Fastening System
- Boston Scientific CorpJul 13, 1993
K931379 · MICROVASIVE INSURG LAPTIE SUTURE LIGATOR
- Davis & Geck, Inc.Jun 12, 1985
K851452 · VALTRAC PURSESTING DEVICE
- Plastafil, Inc.Aug 27, 1984
K841617 · STROVER HOOK
- J. Sklar Mfg. Co., Inc.Apr 23, 1979
K790577 · HEMORRHOIDAL LIGATOR