BEUDAMED
    FDA Enforcement Class II Terminated

    3.2MM X 510MM COCR THD TIP; 14-443053 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-2240-2018 · Reported June 27, 2018

    Enforcement

    Recall Number
    Z-2240-2018
    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

    3.2MM X 510MM COCR THD TIP; 14-443053 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

    001390 105790 324290 974210 820900 512140 428260 915580 017930 671970 055480 615280 506500 569970 053580 367190 932620 015010 141060 820240 941850 682590 401830

    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

    304