BEUDAMED
    FDA Enforcement Class II Terminated

    RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    Recall: Z-2241-2018 · Reported June 27, 2018

    Enforcement

    Recall Number
    Z-2241-2018
    Event ID
    80193
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 27, 2018
    Initiation Date
    May 16, 2018
    Classification Date
    June 15, 2018
    Termination Date
    April 5, 2024
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    Reason

    The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

    Code Info

    001360 008170 106320 330040 952200 924770 446470 446480 337720 032750 971520 957780 295550

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.

    Quantity

    248