BEUDAMED
    FDA Enforcement Class II Terminated

    Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.

    Recall: Z-0410-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0410-2014
    Event ID
    66414
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    July 30, 2013
    Classification Date
    November 26, 2013
    Termination Date
    April 16, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.

    Reason

    Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.

    Code Info

    Part No. 03.702.218S, Lot No. AJM838X

    Distribution

    Nationwide Distribution including IN, MT, HI, and FL.

    Quantity

    40