BEUDAMED
    FDA Enforcement Class II Terminated

    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

    Recall: Z-2797-2015 · Reported September 30, 2015

    Enforcement

    Recall Number
    Z-2797-2015
    Event ID
    72079
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bien Air Dental SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2015
    Initiation Date
    August 27, 2015
    Classification Date
    September 21, 2015
    Termination Date
    March 31, 2016
    Address
    Langgasse 60, N/A, Biel/bienne, N/A, N/A, Switzerland

    Description

    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

    Reason

    Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

    Code Info

    Catalog numbers: 1600939-001 and 1600938-001 Serial numbers concerned: - Ref: 1600939-001: Serial numbers included in the following range: 15B0001 up to 15F0011 - Ref: 1600938-001: Serial numbers included in the following range: 15B0007 up to 15F0027

    Distribution

    Worldwide Distribution - US distribution to one distributor in FL.

    Quantity

    112 (U.S.)