BEUDAMED
    FDA Recall Terminated

    12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

    Recall: Z-1415-2013 · Initiated February 20, 2013

    Recall

    Recall Number
    Z-1415-2013
    Event Number
    64586
    Firm
    Spinal Solutions, LLC
    FEI Number
    3004884943
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 20, 2013
    Posted
    May 27, 2013
    Terminated
    March 26, 2014
    Address
    26157 Jefferson Ave, Murrieta, CA, 92562-9561

    Description

    12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

    Reason

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

    Action

    Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

    Distribution

    USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.

    Quantity

    56 units