BEUDAMED
    FDA Recall Terminated

    Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

    Recall: Z-1146-2015 · Initiated November 30, 2012

    Recall

    Recall Number
    Z-1146-2015
    Event Number
    70383
    Firm
    Biomet Spine, LLC
    FEI Number
    3012447612
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 30, 2012
    Posted
    February 24, 2015
    Terminated
    May 22, 2015
    Address
    310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464

    Description

    Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

    Reason

    Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

    Action

    Biomet Spine LLC (formerly Lanx) sent an Urgent Recall Notification letter to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Lanx Customer Service.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MO, NC, NE, NY, OH, OR, PA, TN, TX, VA, WI. and the countries of: Italy, and Mexico.

    Quantity

    1999