BEUDAMED
    FDA Enforcement Class II Terminated

    Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.

    Recall: Z-2608-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2608-2016
    Event ID
    74656
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard Wolf Medical Instruments Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    May 19, 2016
    Classification Date
    August 19, 2016
    Termination Date
    November 30, 2017
    Address
    353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110, United States

    Description

    Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.

    Reason

    The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.

    Code Info

    Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922

    Distribution

    U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.

    Quantity

    Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces