BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0336-2012 · Initiated February 28, 2011

    Recall

    Recall Number
    Z-0336-2012
    Event Number
    60286
    Firm
    Acute Innovations Llc
    FEI Number
    3005670412
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 28, 2011
    Posted
    December 1, 2011
    Terminated
    December 6, 2011
    Address
    21421 Nw Jacobson Rd, Ste 700, Hillsboro, OR, 97124-9311

    Description

    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.

    Reason

    RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly.

    Action

    The firm, ACUTE Innovation, sent an "URGENT NOTICE: DEVICE RECALL" letter dated February 21, 2011, to all consignees/customers via FED-EX on February 28, 2011. The letter describes the product, problem and actions to be taken. The customers were instructed to identify product having the lot code(s) and quarantine them; return all product from this lot to Acute Innovations immediately using shipping labels provided or return to: Acute Innovations, LLC, 21421 NW Jacobson Rd, Suite 700, Hillsboro, OR, 97124, and if they further distributed this product, notify those customers of this recall and request return of product(s). Customers can call ACUTE Innovation at 1-866-623-4137 for any questions about this recall.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, GA, IL, MN, NC, NY, UT, and WA; and countries of: South Africa.

    Quantity

    299 units (267 in US and 32 to South Africa)