BEUDAMED
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    Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·July 15, 2015

    Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code LXH·October 22, 2008

    Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; Sterile, Rx only. Manufactured by Integra NeuroSciences Implants S.A., Sophia Antipolis Cedex, France; distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538; This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits under catalog number 31223 and 31253.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GCY·May 7, 2010

    Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBG·February 22, 2011

    Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBG·February 22, 2011

    The UNI-CP System; Model Number: 330230SND.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JDR·January 25, 2017

    Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.

    FDA Recall
    Terminated ·Integra Limited·Product code HWC·March 1, 2019

    Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.

    FDA Recall
    Terminated ·Integra Limited·Product code HWC·March 1, 2019

    Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.

    FDA Recall
    Terminated ·Integra Limited·Product code HWC·March 1, 2019

    Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical facilities, where the patient will be under the supervision of trained personnel. The Model SB dermatomes are used in skin banks for the harvesting of cadaver tissues.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GFD·March 11, 2011

    Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.

    FDA Recall
    Terminated ·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code BSP·May 1, 2015

    Ruggles Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set.

    FDA Recall
    Terminated ·J. Jamner Surgical Instruments, Inc.·Product code FWZ·April 24, 2006

    Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·August 17, 2016

    TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·June 22, 2016

    NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

    FDA Enforcement
    Class III ·Terminated·Integra LifeSciences Corp.·March 18, 2020

    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 bone fractures or for bone reconstruction.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·August 31, 2016

    Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·January 15, 2014

    Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp·July 18, 2012

    Panta Nail, Rx only, Sterile,

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·March 29, 2017

    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·May 7, 2014