43 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
FDA Recall
Terminated
·Owen Mumford USA, Inc.·Product code KZH·November 24, 2014
ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG
FDA Recall
Terminated
·Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria·Product code DRX·November 2, 2015
Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
FDA Enforcement
Class II
·Terminated·Owen Mumford USA, Inc.·April 8, 2015
ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
FDA Recall
Terminated
·Acrymed Incorporated·Product code FRO·June 30, 2008
ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG
FDA Enforcement
Class II
·Terminated·Leonhard Lang Medizintechnik GmbH·November 25, 2015
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
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
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
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
FDA Recall
Terminated
·Ebi, Llc·Product code MAX·April 9, 2013
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
FDA Recall
Terminated
·Ebi, Llc·Product code NKB·October 8, 2014
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
FDA Recall
Terminated
·Ebi, Llc·Product code OVE·November 11, 2014
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
FDA Recall
Terminated
·Ebi, Llc·Product code HXX·May 15, 2014
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 Enforcement
Class II
·Terminated·Ebi, Llc·November 27, 2013
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
FDA Enforcement
Class II
·Terminated·Ebi, Llc·December 31, 2014
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
FDA Enforcement
Class II
·Terminated·Ebi, Llc·December 26, 2012
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
FDA Enforcement
Class II
·Terminated·Ebi, Llc·October 9, 2013
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
FDA Enforcement
Class II
·Terminated·Ebi, Llc·June 25, 2014