BEUDAMED
    FDA Recall Terminated

    MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

    Recall: Z-0421-2012 · Initiated August 22, 2011

    Recall

    Recall Number
    Z-0421-2012
    Event Number
    60454
    Firm
    Orthohelix Surgical Designs Inc
    FEI Number
    3000718467
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 22, 2011
    Posted
    January 11, 2012
    Terminated
    February 19, 2012
    Address
    1065 Medina Rd., Suite 500, Medina, OH, 44256

    Description

    MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

    Reason

    The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.

    Action

    Orthohelix Surgical Designs Inc. sent an URGENT RECALL NOTIFICATION letter dated August 22, 2011 to all affected customers. The letter identified the affected products, the problem, and the actions to be taken. Customers were instructed to immediately inventory, remove and return the recalled product to the firm via FedEx or any shipping method with tracking capability. Customers were also requested to notify any affected user facilities of the recall. For any questions call 330-247-1444 or 330-247-1445.

    Distribution

    Nationwide Distribution (USA) - including the states of: CA, CO, CT, FL, GA, IA, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI and WY.

    Quantity

    2,722 units