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Sources: EU EUDAMED, US FDA
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The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are manufactured from titanium alloy. Surgical instrumentation is supplied with the implants in a surgical tray to facilitate the proper insertion of the plates and screws. The ACUTE Innovations Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum. Part Numbers: RBL1301- 50 mm Rib Plate; RBL1302- 75 mm Rib Plate; RBL1303- 115 mm Rib Plate; RBL1304- 155 mm Rib Plate; RBL1305- 215 mm Rib Plate;
FDA Enforcement
Class II
·Terminated·ACUTE Innovations, LLC·February 5, 2014
10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. The product is labeled in parts: "***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY***NON STERILE***SCREW***ACUTE Innovations LLC 21421 NW Jacobson Road, Suite 700 Hillsboro, OR 97124 USA www.acuteinnovations.com*** MediMark Europe Sarl*** 11 rue Emile ZOLA BP 2332****38003 GRENOBLE CEDEX 2 FRANCE" The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies for the rib. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.
FDA Recall
Terminated
·Acute Innovations Llc·Product code HRS·February 28, 2011
The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are manufactured from titanium alloy. Surgical instrumentation is supplied with the implants in a surgical tray to facilitate the proper insertion of the plates and screws. The ACUTE Innovations Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum. Part Numbers: RBL1301- 50 mm Rib Plate; RBL1302- 75 mm Rib Plate; RBL1303- 115 mm Rib Plate; RBL1304- 155 mm Rib Plate; RBL1305- 215 mm Rib Plate;
FDA Recall
Terminated
·ACUTE Innovations, LLC·Product code HRS·October 30, 2013
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
FDA Enforcement
Class I
·Terminated·Engineered Medical Systems,Inc·April 17, 2013
regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code MDI·July 29, 2015
Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code LWP·January 7, 2008
VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code LWP·January 7, 2008
Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 5578
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code 74DWF·August 8, 2003
Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 5579
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code 74DWF·August 8, 2003
Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 4430
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code 74DWF·August 8, 2003
Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 4428
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code 74DWF·August 8, 2003
Sarns brand Retrograde Cardioplegia Cannula, 15 Fr, guidewire stylet, ribbed balloon, manual-inflate. Catalog # 7272
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code 74DWF·August 8, 2003
Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, guidewire stylet, ribbed balloon; catalog number 5580.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DWF·July 7, 2004