55 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SWIN 2017 database, Model YSW4000
FDA Recall
Terminated
·Remel Inc.·Product code LON·January 4, 2019
SWIN 2017 database, Model YSW4000
FDA Enforcement
Class II
·Terminated·Remel Inc.·May 20, 2020
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.
FDA Enforcement
Class II
·Terminated·Espiner Medical Ltd·November 21, 2018
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.
FDA Recall
Terminated
·Espiner Medical Ltd
Yeo Bank
3, Kenn Road
Clevedon United Kingdom·Product code GCJ·June 20, 2018
8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
FDA Recall
Terminated
·Becton Dickinson & Company·Product code KNW·August 1, 2019
BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PSZ·April 3, 2019
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PSZ·April 3, 2019
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SOLITAIRETM ANTERIOR SPINAL SYSTEM is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SolitaireTM System is also indicated for treating fractures of the thoracic and lumbar spine. The SolitaireTM System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
FDA Recall
Terminated
·Biomet Spine, LLC·Product code OVD·February 12, 2016
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTC·July 26, 2019
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTC·July 26, 2019
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
FDA Recall
Terminated
·Panoramic Rental Corp.·Product code EHD·August 19, 2016
Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Inserter products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. FPT - F is FuseLOX, P is Plif, and I is Inserter. Products subject to recall: FuseLOX Lumbar Inserter Inserter - Part Number: FPT0200 Lot Number 6110100. Quantity distributed (8) is found in table on page 5 of 6. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
FDA Recall
Terminated
·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code MAX·April 27, 2012
Kit BD Max StaphSR; Catalog # 443418
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code NQX·July 17, 2019
Kit BD Max MRSA XT; Catalog # 443461
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code NQX·July 17, 2019
Kit BD Max ExK TNA 2; Catalog # 442825
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max Enteric Viral Panel EU Catalog # 443985
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PCH·July 17, 2019
Kit BD Max Cdiff EU; Catalog # 442555
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max Enteric Parasite Panel EU; Catalog # 442960
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PCH·July 17, 2019
Kit BD Max CT/GC/TV; Catalog # 442970
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code OUY·July 17, 2019