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Sources: EU EUDAMED, US FDA
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Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit. Model Number (s) 112x-xx (CT), 108x-xx(T). These are part of the Algovita Spinal Cord Stimulation System. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient s use of the system.
FDA Recall
Terminated
·Nuvectra·Product code LGW·October 11, 2016
Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.
FDA Recall
Terminated
·Orthofix, Inc·Product code MQP·November 19, 2009
Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. Intended to promote fusion of the cervical spine and occipitothoracic junction.
FDA Recall
Terminated
·Blackstone Medical, Inc.·Product code MNI·February 2, 2010
Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the final tightening of set screws in a spinal implant construct.
FDA Recall
Terminated
·Orthofix, Inc.·Product code NKB·April 1, 2011
Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers)
FDA Recall
Terminated
·Interpore Cross International Inc·Product code MQP·January 14, 2005
TraXis Vue Spinal Implant System, Part #2601-090921
FDA Recall
Terminated
·Abbott Spine·Product code MQP·November 2, 2005
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code OVD·June 6, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code OVD·June 6, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code OVD·June 6, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code OVD·June 6, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code OVD·June 6, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code OVD·June 6, 2023
Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.
FDA Recall
Terminated
·Blackstone Medical, Inc.·Product code MNI·May 21, 2009
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 25MM, spinal implant component
FDA Recall
Terminated
·Stryker Spine·Product code KWQ·October 2, 2009
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 31MM, spinal implant component
FDA Recall
Terminated
·Stryker Spine·Product code KWQ·October 2, 2009
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 22MM, spinal implant component
FDA Recall
Terminated
·Stryker Spine·Product code KWQ·October 2, 2009
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code OVD·June 6, 2023
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 37MM, spinal implant component
FDA Recall
Terminated
·Stryker Spine·Product code KWQ·October 2, 2009
DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
FDA Recall
Terminated
·DePuy Spine, Inc.·Product code NKB·November 7, 2012
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 28MM, spinal implant component
FDA Recall
Terminated
·Stryker Spine·Product code KWQ·October 2, 2009