BEUDAMED
    FDA Recall Terminated

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    Recall: Z-3020-2020 · Initiated August 24, 2020

    Recall

    Recall Number
    Z-3020-2020
    Event Number
    86396
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    PHX
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    August 24, 2020
    Terminated
    May 1, 2023
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    Reason

    Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.

    Action

    On 8/24/2020 the firm provided a letter to their consignees with the following instructions: In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of this product. " Extend this information to your accounts that may have this product in their possesrion. " Identify and quarantine any of the subject devices in your inventory (including loaer kits). " Complete and return the attached Recall Inventory Response Form to Exactech via email a [email protected].

    Distribution

    Domestic Distribution: KS, CA, AR, NY, OH, IL, WI, AZ, LA, KY, VA, IN, TX, HI, MN, FL, TN, GA, ID, ME, CO, WA, SC. International Distribution: Austria, Australia, Germany, France, Spain, Italy, Japan, United Kingdom, Luxembourg, Netherlands, South Africa.

    Quantity

    149 devices