129 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·March 16, 2022
Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·June 11, 2014
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MAL·January 14, 2022
Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code KWP·November 3, 2008
ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
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
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 29, 2022
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DSY·January 20, 2010
ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018
ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018
ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018
ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018
ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018
ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018
Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT220 2.3mm (D) x 20.0 mm (L) STERILE.
FDA Recall
Terminated
·Implant Innovations, Inc.·Product code DZI·December 2, 2003