50 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code OQY·January 5, 2015
Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·February 6, 2009
EBI Trochanteric 11mm Long Nail.
FDA Recall
Terminated
·Product code JDS·June 24, 2005
EBI VueCath Endoscopic Spinal System
FDA Recall
Terminated
·Product code GWG·June 17, 2003
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
FDA Recall
Open, Classified
·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code DPZ·May 19, 2023
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code OQY·December 30, 2014
EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle Arthrodesis Nail Instr., Part Number 469055.
FDA Recall
Terminated
·Product code HXI·March 16, 2005
EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory P/N 469060.
FDA Recall
Terminated
·Product code HXI·March 16, 2005
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LOE·February 19, 2018
OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054
FDA Recall
Terminated
·Product code MQV·October 23, 2007
Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
FDA Recall
Terminated
·Ebi, Llc·Product code LXH·August 13, 2013
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
FDA Recall
Terminated
·Ebi, Llc·Product code HWC·August 22, 2013
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
FDA Recall
Terminated
·Ebi, Llc·Product code NKB·September 16, 2010
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
FDA Recall
Terminated
·Ebi, Llc·Product code HXX·September 29, 2012
48" Lead Wires, Replacement Part Number: 1067724-4
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
FDA Recall
Terminated
·Ebi, Llc·Product code HXX·February 7, 2013
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
FDA Recall
Terminated
·Ebi, Llc·Product code HXX·September 24, 2013
20" Lead Wires, Replacement Part Number: 1067724-2
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024