Clamp, Surgical, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
300 adverse event reports on file
- LEWIN BONE HOLD CLAMP 7Jul 17, 2026MalfunctionIntegra Lifesciences Mansfield3014334038-2026-00057
- PURSTRINGJun 12, 2026MalfunctionCovidien2647580-2026-01733
- LEWIN CLAMPJun 9, 2026InjuryIntegra Lifesciences Production CorporationMW5189083
- JARIT LEWIN CLAMPJun 9, 2026InjuryIntegra Lifesciences CorporationMW5189084
- PURSTRINGJun 3, 2026MalfunctionCovidien2647580-2026-01592
- UNKNOWN PURSTRING DEVICEApr 29, 2026MalfunctionDavis & Geck Caribe Ltd9612501-2026-01196
- PURSTRINGApr 7, 2026MalfunctionCovidien2647580-2026-00971
- ROD GRIPPERMar 25, 2026MalfunctionZimmer Biomet Spine, Inc.3012447612-2026-00082
- MILLENNIUM SURGICAL CORPMar 23, 2026MalfunctionMillennium Surgical Corp3004215117-2026-00001
- PURSTRINGMar 4, 2026MalfunctionCovidien2647580-2026-00586
Event type breakdown
Recalls
9 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-0936-2025 · View FDA record ↗ - Medtronic Perfusion SystemsOpen, ClassifiedJul 23, 2024
TourniKwik Tourniquet Set (CFN 79012)
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Z-2423-2024 · View FDA record ↗ - Medtronic Perfusion SystemsOpen, ClassifiedMay 10, 2024
Medtronic Tourniquet Sets:
Potential for unsealed sterile packing.
Z-1798-2024 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedAug 29, 2013
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthr
Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
Z-2130-2013 · View FDA record ↗ - Smith & Nephew, Inc., Endoscopy Div.TerminatedJul 7, 2005
Smith & Nephew Grasper, Cupped 3.4mm
Cupped Grasper Handle marked incorrectly as Duckbill Upbiter
Z-0973-05 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedUnknown
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Z-2592-2018 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedUnknown
MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Z-2593-2018 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedUnknown
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Z-2594-2018 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedUnknown
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Z-2595-2018 · View FDA record ↗
Registered firms
276 firms currently registered for this product code
Perfect Ophthalmic Instruments Fze
Dubai Dubayy, AE
Deroyal Intercontinental, S.r.l.
SANTIAGO, DO
Aspen Surgical Products, Inc.
Caledonia, MI, US
Eltek Instruments (pvt.) Ltd.
Sialkot Punjab, PK
Dewimed Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
J & J Instruments, Llc
Stratford, CT, US
Stone Instruments Co.
SIALKOT Punjab, PK
Medxl
ARDMORE, OK, US
Naqeebe Enterprises
SIALKOT Punjab, PK
Sterigenics Us Llc
Gurnee, IL, US
Technimen Skillers
SIALKOT Punjab, PK
Huaian Frimen Co., Ltd
Huaian Jiangsu, CN
Itm Industria De Tecnologias Medicas Ltda
CANOAS Rio Grande do Sul, BR
Garish Apparels
Wazirabad Punjab, PK
Suban Instruments Hungary Co.
DEBRECEN Hajdu-Bihar, HU
Isomedix Operations, Inc.
Libertyville, IL, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Covidien
North Haven, CT, US
Mian Shahid Corp.
MUZAFFAR PUR, SIALKOT Punjab, PK
Kb Components Dallas, Inc.
ARLINGTON, TX, US
Key Surgical, Llc
Eden Prairie, MN, US
Elmed, Inc.
Glendale Heights, IL, US
Hexamed Pvt Ltd
Sialkot Punjab, PK
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Integra Lifesciences Production Corporation
Mansfield, MA, US
510(k) clearances
32 clearances for this product code
- Standard BariatricsMay 2, 2016
K153358 · Standard Clamp
- Thomasville Medical Assoc.Feb 4, 1994
K930315 · THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE
- Mar-Med Co.Mar 18, 1993
K924223 · MAR-MED LIVER STRAP
- Miltex Instrument Co.Jul 21, 1992
K922659 · GENERAL SURGERY CLAMP AND NEEDLE HOLDER
- Ideal Medical, Inc.Dec 31, 1991
K914913 · GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST
- Solos Endoscopy, Inc.Apr 18, 1990
K900956 · GS-7100 CHOLANGIOGRAM CLAMP, 5MM
- United States Surgical, A Division of Tyco HealthcApr 9, 1990
K901107 · MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
- Applied Medical TechnologiesOct 24, 1989
K895726 · VESSEL OCCLUDER