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ACUTE Innovations, LLC recalls The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to sta
Recalled February 5, 2014 · FDA recall Z-0852-2014 · ACUTE Innovations
Hazard
The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery. · FDA Class II
Units
176 units
Sold at
US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.
Description
The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.
Product
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;
Manufacturer(s)
ACUTE Innovations, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →