BEUDAMED
    FDA Recall 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 · Initiated August 14, 2015

    Recall

    Recall Number
    Z-2539-2015
    Event Number
    71972
    Firm
    Limacorporate S.p.A Via Nazionale 52 San Daniele Del Friuli Italy
    FEI Number
    3008021110
    Product Code
    KWT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 14, 2015
    Posted
    September 2, 2015
    Terminated
    February 26, 2016

    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.

    Action

    Lima Corporate sent an Urgent Attention Recall letter on August 11, 2015, to US distributors and Sales Agents. The affected customers were instructed to examine their inventory, return the affected lots to the recalling firm, and complete a response form.

    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