BEUDAMED
    FDA Enforcement Class II Terminated

    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

    Recall: Z-2539-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2539-2015
    Event ID
    71972
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    August 14, 2015
    Classification Date
    September 2, 2015
    Termination Date
    February 26, 2016
    Address
    Via Nazionale 52, N/A, San Daniele Del Friuli, N/A, N/A, Italy

    Description

    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

    Reason

    The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.

    Code Info

    Lot Numbers: 14AA234, 14AA235, 14AA233

    Distribution

    US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to Australia.

    Quantity

    110 units