Recall Z-1148-2012 ยท DYJ Retainer, Screw Expansion, Orthodontic
Ormco Corporation
AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by this recall are as follows: Part Number: 600-4000 (Kits-include 10 Right 600-4000 and 10 Left Assemblies). Lot Numbers: 070990588, 070976869, 060971515, 060971514, 04094278D Part Number: 600-4040 (5-Pack, Left Assembly). Lot Numbers: 0
| Date | Mar 5, 2012 (initiated Oct 2, 2009) |
| Status | Terminated |
| Reason | Manufacturing Error: There is a potential for a braze joint failure in the upper telescopic rod assembly. Although an incident could occur in which the eyelet loses connection from the rod, there is no risk of swallowing or aspirating the appliance because it will still be attached to the patient's crown. |
| Root cause | Process control |
| Action | Ormco sent a Urgent Medical Device Recall letter dated October 9, 2009,( via USPS 1st class mail) to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to return the affected lot numbers of the 5-Pack Left and Right Telescopic Rod Assemblies (600-4040 and 600-4041) and the Left and Right Telescopic Rod Assemblies contained within the AdvanSync Kit (600-4000). The affected parts are identified by the items contained inside the wells titled, "Left Rods" and "Right Rods." The remaining items withi |
| Quantity | 3,635 Units (237 kits, 315-pack left assemblies and 305-pack right assemblies) |
| Distribution | Worldwide- USA (nationwide) and the countries of Europe, Australia, Canada and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.