BEUDAMED
    FDA Recall Terminated

    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

    Recall: Z-0423-2016 · Initiated November 10, 2015

    Recall

    Recall Number
    Z-0423-2016
    Event Number
    72646
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    LRZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 10, 2015
    Posted
    December 16, 2015
    Terminated
    September 8, 2016
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

    Reason

    The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

    Action

    The firm, Aesculap Implant Systems, sent a "URGENT MEDICAL DEVICE RECALL" letter dated Nov. 23, 2015 to all consignees via certified letter with return receipt. Distributors and sales reps will be notified via e-mail with return receipt. The letter described the product, problem and actions to be taken. The consignees were instructed to review the product recall notification in its entirety and ensure all users your organization and other concerned persons are informed; determine your current inventory; do not destroy any affected product; immediately remove and return the affected instruments-these instruments may be located within Set ST0485; use the U joint screwdriver, ME014R in place of the SJ706R of which is already part of set ST0485; If you require Customer Service assistance please call: Customer Service: 866-229-3002 or Email: [email protected]., and complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance Department via mail to: Aesculap Inc., 615 Lambert Pointe Drive, Hazelwood, MO 63042; fax to: 610-791-6882 or email to: [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). A replacement for the SJ607R will be sent to you when one becomes available (ME190R). If you have any questions, contact via email: [email protected]/Tel: 610-984-9414 or email: [email protected]/Tel: 610-984-9043.

    Distribution

    Worldwide Distribution: US (nationwide) and country of: Canada.

    Quantity

    41