Class 2 Device Recall AdvanSync, an orthodontic expansion screw

• Date Initiated by Firm: October 02, 2009
• Date Posted: March 05, 2012
• Recall Status: Terminated on March 05, 2012
• Recall Number: Z-1148-2012
• Recall Event ID: 60657
• Product Classification: Retainer, screw expansion, orthodontic - Product Code DYJ
• Product: 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: 080901333, 080902356, 070981416, 060971299, 060976084; ; Part Number: 600-4041 (5-Pack, Right Assembly). Lot Numbers: 080902357, 080901335, 070981417, 060971304, 060976079
• Code Information: 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: 080901333, 080902356, 070981416, 060971299, 060976084 Part Number: 600-4041 (5-Pack, Right Assembly). Lot Numbers: 080902357, 080901335, 070981417, 060971304, 060976079
• Recalling Firm/ Manufacturer: Ormco Corporation; 1332 S Lone Hill Ave; Glendora CA 91740
• For Additional Information Contact: 909-962-5600
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 within the kit are not affected by this recall notification; therefore, there is no need to return the entire kit. Customers were instructed that any product which they have in stock will be replaced at no charge or credited to their account. Customers were instructed to contact Ormco Customer Care at (800) 854-1741 (ext. 1) directly to handle the arrangements of a quick return and replacement. The affected product should be returned to Ormco Corporation at the following address: Ormco Corporation, 1332 South Lone Hill Ave., Glendora, CA 91740. Customers were instructed to label their returned product "RECALLED PRODUCT Attention: Customer Returns". In addition, customers were asked to complete the enclosed Return Form and return it by fax at (909) 962-5605.
• Quantity in Commerce: 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.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.