Integra LifeSciences Corp.
152 recalls on record · Latest: Mar 12, 2025
FDA Devices Moderate Apr 24, 2019
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
FDA Devices Moderate Apr 24, 2019
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
FDA Devices Moderate Apr 24, 2019
Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
FDA Devices Moderate Apr 24, 2019
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
FDA Devices Moderate Apr 24, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
FDA Devices Moderate Apr 24, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
FDA Devices Moderate Apr 24, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
FDA Devices Moderate Aug 8, 2018
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient dur…
FDA Devices Moderate Aug 8, 2018
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagno…
FDA Devices Moderate Aug 8, 2018
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient …
FDA Devices Moderate May 16, 2018
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound hea…
FDA Devices Moderate May 2, 2018
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
FDA Devices Moderate May 2, 2018
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description …
FDA Devices Moderate Mar 7, 2018
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of t…
FDA Devices Moderate Mar 29, 2017
Panta Nail, Rx only, Sterile,
FDA Devices Low Mar 15, 2017
The UNI-CP System; Model Number: 330230SND.
FDA Devices Moderate Oct 12, 2016
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to…
FDA Devices Moderate Oct 12, 2016
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and ter…
FDA Devices Moderate Oct 12, 2016
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardbo…
FDA Devices Moderate Oct 12, 2016
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a…
FDA Devices Moderate Oct 12, 2016
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Fiv…
FDA Devices Moderate Aug 31, 2016
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of…
FDA Devices Moderate Aug 17, 2016
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixatio…
FDA Devices Moderate Aug 17, 2016
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
FDA Devices Moderate Aug 3, 2016
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of e…
FDA Devices Moderate Jul 6, 2016
Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing…
FDA Devices Moderate Jun 8, 2016
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
FDA Devices Moderate Jun 8, 2016
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
FDA Devices Moderate May 27, 2015
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tippe…
FDA Devices Moderate May 27, 2015
The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tippe…
FDA Devices Moderate Dec 24, 2014
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, C…
FDA Devices Moderate Dec 10, 2014
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator …
FDA Devices Moderate Aug 20, 2014
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) Th…
FDA Devices Moderate Jul 23, 2014
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
FDA Devices Moderate Jul 9, 2014
Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Hea…
FDA Devices Moderate Jul 9, 2014
MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (8…
FDA Devices Moderate Jul 2, 2014
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized …
FDA Devices Moderate Jun 11, 2014
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary …
FDA Devices Moderate Feb 26, 2014
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical A…
FDA Devices Moderate Feb 19, 2014
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K06…
FDA Devices Moderate Jan 15, 2014
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made…
FDA Devices Moderate Nov 20, 2013
Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid …
FDA Devices Moderate Oct 30, 2013
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, S…
FDA Devices Moderate Oct 30, 2013
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische,…
FDA Devices Moderate Oct 30, 2013
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizin…
FDA Devices Moderate Oct 30, 2013
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische,…
FDA Devices Moderate Jul 17, 2013
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for us…
FDA Devices Moderate Mar 20, 2013
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspira…
FDA Devices Moderate Mar 6, 2013
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasp…
FDA Devices Moderate Aug 8, 2012