BEUDAMED
    FDA Recall Terminated

    PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.

    Recall: Z-1814-2016 · Initiated April 11, 2016

    Recall

    Recall Number
    Z-1814-2016
    Event Number
    74025
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 11, 2016
    Posted
    May 25, 2016
    Terminated
    May 30, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.

    Reason

    The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.

    Action

    Zimmer Biomet has initiated a voluntary recall of the PerFuse Decompression Instrument, following an investigation which identified that the Trocar and Plunger Assemblies are missing from the instrument. The firm contacted customers via telephone and e-mail on March 28, 2016; and official recall notices were mailed via FedEx on 4/11/2016. Customers were instructed to quarantine recalled items, Complete the Certificate of Acknowledgment and email a copy to [email protected]; Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or Call (800)FDA-1088 . Questions related to this recall should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.

    Quantity

    22