BEUDAMED
    FDA Enforcement Class II Terminated

    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

    Recall: Z-0167-2016 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0167-2016
    Event ID
    72345
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2015
    Initiation Date
    October 6, 2015
    Classification Date
    October 27, 2015
    Termination Date
    July 15, 2016
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

    Reason

    Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

    Code Info

    Part Number 202.212 Lot Number 3420620

    Distribution

    US Distribution to the state of : TN

    Quantity

    98