Brand

Integra Lifesciences Corp. Recalls

146 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Integra Lifesciences Corp..

146Total Recalls
5Critical
997,649Units Affected
Feb 6, 2025Most Recent
All Recalls

Every Integra Lifesciences Corp. Recall

Sorted by most recent. Click any recall for full details.

146 recalls
High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
Medical Implants·2,029 affected·Mar 8, 2019
High RiskFDA
Integra Lifesciences Corp.
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a...
Surgical Devices·95 affected·Jun 29, 2018
High RiskFDA
Integra Lifesciences Corp.
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient d...
Surgical Devices·409 affected·Jun 29, 2018
High RiskFDA
Integra Lifesciences Corp.
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to suppor...
Surgical Devices·1 affected·Jun 29, 2018
High RiskFDA
Integra Lifesciences Corp.
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive ...
Medical Devices·766 affected·Mar 6, 2018
High RiskFDA
Integra Lifesciences Corp.
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product ...
Medical Devices·1,619 affected·Dec 20, 2017
High RiskFDA
Integra Lifesciences Corp.
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a co...
Surgical Devices·155 affected·Sep 26, 2017
High RiskFDA
Integra Lifesciences Corp.
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Medical Devices·250 affected·Aug 18, 2017
High RiskFDA
Integra Lifesciences Corp.
Panta Nail, Rx only, Sterile,
Medical Devices·4,449 affected·Mar 3, 2017
RecallFDA
Integra Lifesciences Corp.
The UNI-CP System; Model Number: 330230SND.
Medical Devices·39 affected·Jan 25, 2017
High RiskFDA
Integra Lifesciences Corp.
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary pa...
Surgical Devices·18 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek p...
Surgical Devices·14 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged...
Medical Devices·1 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch,...
Surgical Devices·10 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyve...
Medical Devices·9 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
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...
Medical Devices·120 affected·Jul 21, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal ...
Medical Devices·495 affected·Jul 20, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue ...
Medical Devices·111 affected·Jul 20, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by ...
Medical Devices·27 affected·Jul 1, 2016
High RiskFDA
Integra Lifesciences Corp.
Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, ther...
Medical Implants·12 affected·Apr 29, 2016
CriticalFDA
Integra Lifesciences Corp.
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Surgical Devices·2,487 affected·Mar 7, 2016
CriticalFDA
Integra Lifesciences Corp.
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Surgical Devices·30,146 affected·Mar 7, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (compris...
Respiratory Devices·2,506 affected·Nov 7, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgica...
Surgical Devices·6,358 affected·Sep 29, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
Surgical Devices·28,752 affected·Jul 9, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Compo...
Medical Implants·4 affected·Jun 27, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to...
Surgical Devices·1,250 affected·Jun 11, 2014
High RiskFDA
Integra Lifesciences Corp.
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)...
Medical Devices·94 affected·Jun 9, 2014
High RiskFDA
Integra Lifesciences Corp.
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c De...
Surgical Devices·61 affected·May 19, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with ...
Diagnostic Devices·49 affected·Apr 16, 2014
High RiskFDA
Integra Lifesciences Corp.
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): ...
Medical Implants·40 affected·Jan 22, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasoni...
Surgical Devices·17,253 affected·Dec 5, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08...
Cardiac Devices·78 affected·Nov 13, 2013
High RiskFDA
Integra Lifesciences Corp.
Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to pr...
Medical Devices·37 affected·Aug 29, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur med...
Respiratory Devices·503 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur m...
Respiratory Devices·42 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft...
Respiratory Devices·109 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur m...
Respiratory Devices·16 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrume...
Surgical Devices·22,500 affected·Feb 12, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indi...
Medical Devices·154 affected·Feb 1, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended f...
Medical Devices·2,437 affected·Feb 9, 2012