BEUDAMED
    FDA Recall Terminated

    Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510

    Recall: Z-1961-2019 · Initiated June 10, 2019

    Recall

    Recall Number
    Z-1961-2019
    Event Number
    83099
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    FSM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 10, 2019
    Terminated
    September 10, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510

    Reason

    Lack of an adequate sterilization validation.

    Action

    Medical Device Recall notification letters dated 6/10/19 were sent to customers.

    Distribution

    The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.

    Quantity

    1257