BEUDAMED
    FDA Enforcement Class II Terminated

    Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.

    Recall: Z-2428-2020 · Reported July 1, 2020

    Enforcement

    Recall Number
    Z-2428-2020
    Event ID
    85111
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PROVIDENCE MEDICAL TECHNOLOGIES
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 1, 2020
    Initiation Date
    March 29, 2019
    Classification Date
    June 25, 2020
    Termination Date
    May 27, 2022
    Address
    3875 Hopyard Rd Ste 300, N/A, Pleasanton, CA, 94588-8527, United States

    Description

    Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.

    Reason

    There may be dimensional manufacturing error that represents a potential safety risk to patients.

    Code Info

    Model Number; PD 32 601 - ALLY Bone Screw L 10mm Lot Number: 046164 Model Number: PD 32 602 - ALLY Bone Screw L 12mm Lot Numbers: 045375 045646 045647 046313

    Distribution

    US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX.

    Quantity

    208 units