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U.S. Department of Health and Human Services

Class 2 Device Recall SnapLink Buccal Tube

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  Class 2 Device Recall SnapLink Buccal Tube see related information
Date Initiated by Firm January 17, 2020
Date Posted February 06, 2020
Recall Status1 Open3, Classified
Recall Number Z-1257-2020
Recall Event ID 84538
Product Classification Tube, orthodontic - Product Code DZD
Product SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Code Information All Lots UDI #s: 00889989002652 & 00889989002669
Recalling Firm/
Manufacturer		 Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora CA 91740-5339
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
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 ormcocustcare@kavokerr.com 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 ormcocustcare@kavokerr.com within 10 business days. If
Quantity in Commerce 3,632,493 brackets
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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