BEUDAMED
    FDA Enforcement Class II Terminated

    12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    Recall: Z-2476-2012 · Reported October 10, 2012

    Enforcement

    Recall Number
    Z-2476-2012
    Event ID
    62110
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 10, 2012
    Initiation Date
    April 1, 2011
    Classification Date
    September 28, 2012
    Termination Date
    May 16, 2014
    Address
    345 E Main St, N/A, Warsaw, IN, 46580-2746, United States

    Description

    12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

    Reason

    Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp

    Code Info

    All lots distributed from lot 69998600 (2/20/1996) to present

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.

    Quantity

    231,641 all lots, all sizes