BEUDAMED
    FDA Enforcement Class II Terminated

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    Recall: Z-0644-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0644-2017
    Event ID
    75502
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 30, 2016
    Initiation Date
    October 3, 2016
    Classification Date
    November 19, 2016
    Termination Date
    July 6, 2017
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    Reason

    The peel pouches for the affected reaming rods and extraction hooks are delaminating.

    Code Info

    Catalog ID 351.709S, Lot Numbers: 9913251; 9913252; 9913254; 9913256; 9913259; 9913260; 9950460; 9950461; 9950462; 9950463; 9950464; 9963747; 9963748; 9963749; 9963751; 9963752; 9963753; 9963755; 9963756; 9963757; 9985371; 9985372; 9985373; 9985374; H040508; H040509; H040510; H040511; H040512; H040517; H040518; H040519; H060103; H060104; H060105; H060106; H060107; H060108; H060114; H060115; H060116; H080034; H080035; H080036; H080037; H080038; H080039; H080040; H080041; H080081; H080082; H080083; H080084; H080085; H080086; H080087; H080088; H080089; H105527; H105528; H105529; H105530.

    Distribution

    Distributed Nationwide

    Quantity

    2,157 units