AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part

FDA device recall Z-1148-2012 · posted 2012-03-05 · Terminated

Recall details

Recalling firm

Ormco Corporation

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

DYJ

Quantity affected

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.

Date initiated

2009-10-02

Date posted

2012-03-05

Date terminated

2012-03-05

Location

Glendora, CA