BEUDAMED
    FDA Enforcement Class II Terminated

    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;

    Recall: Z-0852-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0852-2014
    Event ID
    67117
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ACUTE Innovations, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    October 30, 2013
    Classification Date
    January 28, 2014
    Termination Date
    March 13, 2014
    Address
    21421 NW Jacobson Rd Ste 700, Hillsboro, OR, 97124-9311, United States

    Description

    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;

    Reason

    The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.

    Code Info

    LOT numbers: RBL1301 for 50 mm Rib Plate: L1209002; L1302002; L1308001; RBL1302 for 75 mm Rib Plate: L1209003; L1302003; RBL1303 for 115 mm Rib Plate: L1209004; L1302004; RBL1304 for 155 mm Rib Plate: L1209005; RBL1305 for 215 mm Rib Plate: L1209006;

    Distribution

    US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.

    Quantity

    176 units