BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.

    Recall: Z-0656-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0656-2017
    Event ID
    75580
    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 31, 2016
    Classification Date
    November 23, 2016
    Termination Date
    June 12, 2017
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.

    Reason

    Non-conforming material used.

    Code Info

    Part Number 352.040 - Lot # 9947895, L084498 Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974

    Distribution

    US Nationwide Distribution.

    Quantity

    198 units