BEUDAMED
    FDA Recall 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 · Initiated October 30, 2013

    Recall

    Recall Number
    Z-0852-2014
    Event Number
    67117
    Firm
    ACUTE Innovations, LLC
    FEI Number
    3005670412
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 30, 2013
    Posted
    January 28, 2014
    Terminated
    March 13, 2014
    Address
    21421 NW Jacobson Rd, Ste 700, Hillsboro, OR, 97124-9311

    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.

    Action

    The firm sent the Urgent Notice: Device Recall letter, dated 30 Oct. 2013, to their consignees. The recall notification letter requested consignees to return the product to Acute and a return authorization number provided. Consignees should contact Acute Innovations Customer Service at 866-623-4137 for any questions regarding this recall notification.

    Distribution

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

    Quantity

    176 units