BEUDAMED
    FDA Recall Terminated

    Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

    Recall: Z-1246-2013 · Initiated April 17, 2009

    Recall

    Recall Number
    Z-1246-2013
    Event Number
    53487
    Firm
    Spinal Elements, Inc
    FEI Number
    3004893332
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 17, 2009
    Posted
    May 7, 2013
    Terminated
    May 7, 2013
    Address
    3115 Melrose Dr, Suite 200, Carlsbad, CA, 92010-6690

    Description

    Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

    Reason

    Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

    Action

    Spinal Elements sent Urgent Medical Device Recall notification letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Chief Technology Officer at Spinal Elements for questions about the recall letter.

    Distribution

    Distributed in OH and PA.

    Quantity

    68 units total