BEUDAMED
    FDA Recall Terminated

    Comprehensive Reverse Shoulder System Humeral Tray Model 115340

    Recall: Z-1103-2017 · Initiated December 20, 2016

    Recall

    Recall Number
    Z-1103-2017
    Event Number
    75971
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    PAO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 20, 2016
    Posted
    February 11, 2017
    Terminated
    August 29, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Comprehensive Reverse Shoulder System Humeral Tray Model 115340

    Reason

    Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.

    Action

    On 12/20/2016, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. On 2/1/2017, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Surgeons, Risk Managers, and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The 2/1/2017 notice identified additional product lots that had been added to the affected product list, as well as included patient monitoring guidance for surgeons.

    Distribution

    Nationwide. CANADA AUSTRALIA CHILE COLOMBIA KOREA Netherlands

    Quantity

    4388