BEUDAMED
    FDA Recall Terminated

    Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541 Compress Device Centering Sleeve 19mm 178545 Compress Device Centering Sleeve 23mm 178544 Compress Device Centering Sleeve 22mm 178738 Compress Device Centering Sleeve 28mm 178542 Compress Device Centering Sleeve 20mm 32-481123 Compress Instrument Drill For Anti-Rotation Pin 178757 Mini Taper Spindle, 400 lbs, Extra Small 178758 Mini Taper Spindle, 600 lbs, Extra Small 178759 Mini Taper Spindle, 800 lbs, Extra Small 178787 Short Mini Taper Spindle, 400 lbs, Extra Small 178788 Short Mini Taper Spindle, 600 lbs, Extra Small 178789 Short Mini Taper Spindle, 800 lbs, Extra Small

    Recall: Z-0642-2019 · Initiated October 12, 2018

    Recall

    Recall Number
    Z-0642-2019
    Event Number
    81404
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KWA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 12, 2018
    Terminated
    April 17, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541 Compress Device Centering Sleeve 19mm 178545 Compress Device Centering Sleeve 23mm 178544 Compress Device Centering Sleeve 22mm 178738 Compress Device Centering Sleeve 28mm 178542 Compress Device Centering Sleeve 20mm 32-481123 Compress Instrument Drill For Anti-Rotation Pin 178757 Mini Taper Spindle, 400 lbs, Extra Small 178758 Mini Taper Spindle, 600 lbs, Extra Small 178759 Mini Taper Spindle, 800 lbs, Extra Small 178787 Short Mini Taper Spindle, 400 lbs, Extra Small 178788 Short Mini Taper Spindle, 600 lbs, Extra Small 178789 Short Mini Taper Spindle, 800 lbs, Extra Small

    Reason

    Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.

    Action

    Zimmer notified accounts on 12/13/18 via email and FedEx (both original and expanded accounts) as a follow up to the medical device correction notification dated October 12, 2018. Zimmer Biomet identified additional item numbers that are within the scope of this issue. . Distributors letter identify the issue and their responsibilities, which include: Reviewing the correction notification and ensuring affected team members are aware of the contents. Offering assistance in ensuring users are aware of the updated surgical technique and how to locate it. Destroying previous copies of the surgical technique. Completing the Certification of Acknowledgement. Updated surgical techniques 1110.2-GLBL-en REV0818 and BMET0188.2 REV111218 for the Compress and Mini Compress systems are used, effective immediately, for surgeries that require the affected items. a. Access the full surgical techniques at www.zimmerbiomet.com by navigating to the Limb Salvage specialty and then Bone Compressive Devices under the Medical Professionals menu.

    Distribution

    Nationwide Foreign: CANADA ARGENTINA AUSTRALIA BELGIUM CHILE FINLAND JAPAN NETHERLANDS

    Quantity

    323 devices US; 208 distributed OUS