BEUDAMED
    FDA Recall Terminated

    SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only

    Recall: Z-1258-2020 · Initiated January 17, 2020

    Recall

    Recall Number
    Z-1258-2020
    Event Number
    84538
    Firm
    Ormco/Sybronendo
    FEI Number
    2016150
    Product Code
    DZD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 17, 2020
    Posted
    February 6, 2020
    Terminated
    September 30, 2024
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    Description

    SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only

    Reason

    The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.

    Action

    ISSUE: Ormco received an increase in complaints relating to lower Snaplink buccal tube slide doors not staying closed. We received 140 complaints from 2015 to Sep 2019, with no reported patient injuries. The incidence of this issue appears to be low. Approximately <0.1% of the Snaplink Buccal Tubes experience this issue due to an interaction between the Snaplink slide and the pin that enables the door to stay open or closed. RISK: In the event of functional failure, broken/damaged Snaplink may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If a patient or clinician does not notice this issue, it may extend treatment by approximately 1-3 months, depending on the patients visit schedule. If you experience this failure, please follow the recommendations below. RECOMMENDATION: Ormco is not requesting removal of Snaplink, from your facility. You can continue to use the product in your inventory. If you experience Snaplink buccal tube slide doors not staying closed, Ormco requests you to: (1) Call Ormco customer service at 1-800-854-1741 or email [email protected] to log any complaints related to this issue. (2) For patients who had Snaplink lowers placed, check the patient records and determine if you need an additional patient visit to check the integrity of the door to ensure it remains closed. (3) Instruct patients to check bracket after each brush to ensure bracket door remains closed. If door appears open, instruct patients to contact your office to schedule an appointment. (4) If the bracket door does not stay closed, use a double over tie, per typical orthodontic practices (Refer to pictures below) or remove the Snaplink and replace it with a new device. If the Snaplink is removed, please contact customer care (1-800-854-1741) for the product to be returned. (5) Complete the enclosed acknowledgement form and email the form to [email protected] within 10 business days. If

    Distribution

    US:AK,AL,AR,AZ,CA,CO,CN,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV,WY OUS: Argentina, Australia, Barbados, Bahamas, Bolivia, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Cambodia, Korea, Cayman Islands, Sri Lanka, Myanmar, Mexico, Malaysia, Netherlands, Nepal, Panama, Philippines, Paraguay, Russian Federation, Singapore, Thailand, Taiwan, Uruguay, Viet Nam, South Africa

    Quantity

    3,632,493 brackets