BEUDAMED
    FDA Recall Terminated

    Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.

    Recall: Z-2152-2015 · Initiated March 12, 2015

    Recall

    Recall Number
    Z-2152-2015
    Event Number
    70961
    Firm
    Biomet Spine, LLC
    FEI Number
    3010928172
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 12, 2015
    Posted
    July 20, 2015
    Terminated
    December 21, 2015
    Address
    399 Jefferson Rd, Parsippany, NJ, 07054-3707

    Description

    Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.

    Reason

    Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.

    Action

    Biomet Spine issued an Urgent Medical Device Recall Notice/Response Form dated 3/12/2015 to their affected customers.

    Distribution

    Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands.

    Quantity

    4,765 units