Recall Z-1258-2020 ยท DZD Tube, Orthodontic
Ormco/Sybronendo
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
| Date | Feb 6, 2020 (initiated Jan 17, 2020) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 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, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.