BEUDAMED
    FDA Enforcement Class II Terminated

    Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.

    Recall: Z-0813-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0813-2018
    Event ID
    79274
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alto Development Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    October 23, 2017
    Classification Date
    March 1, 2018
    Termination Date
    April 30, 2019
    Address
    5206 Asbury Rd, N/A, Wall Township, NJ, 07727-3609, United States

    Description

    Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.

    Reason

    Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.

    Code Info

    080-271 (9108 units); 080-351 (41712 units); 080-401(219954 units); 080-403 (1368 units); 080-451 (83190 units); 080-481 (32556 units); 080-501 (23598 units)

    Distribution

    Worldwide Distribution - USA Distribution

    Quantity

    411,486 units