BEUDAMED
    FDA Recall Terminated

    Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.

    Recall: Z-1198-2017 · Initiated January 3, 2017

    Recall

    Recall Number
    Z-1198-2017
    Event Number
    76257
    Firm
    Allen Medical Systems, Inc. One Post Office Square
    FEI Number
    1221538
    Product Code
    HST
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 3, 2017
    Posted
    February 14, 2017
    Terminated
    October 3, 2018
    Address
    Acton, MA, 01720

    Description

    Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.

    Reason

    During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.

    Action

    The distributor was notified of the recall via email on January 3, 2017. The letter identified the affected product, problem and actions to be taken. The letter instructs the consignee to remove the product from service and follow instructions to return the device to Allen Medical for repair.

    Distribution

    US state of FL

    Quantity

    112 devices