BEUDAMED
    FDA Recall Open, Classified

    Equinoxe Humeral Stem, Primary, Press Fit, 11mm

    Recall: Z-0884-2021 · Initiated November 9, 2020

    Recall

    Recall Number
    Z-0884-2021
    Event Number
    86760
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    HSD
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    November 9, 2020
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Equinoxe Humeral Stem, Primary, Press Fit, 11mm

    Reason

    Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

    Action

    Exactech distributed the recall notice titled, "URGENT PRODUCT RECALL NOTICE" to consignees in possession of affected inventory in the US and Australia on November 9, 2020 via email. In order to comply with the notice, consignees have been instructed to: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory. " Complete and return the attached Recall Inventory Response Form to Exactech.

    Distribution

    Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.

    Quantity

    14 devices