Recall Z-1330-2014 ยท DYW Bracket, Plastic, Orthodontic
Ormco/Sybronendo
Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
| Date | Apr 4, 2014 (initiated Mar 25, 2014) |
| Status | Terminated |
| Reason | Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction. |
| Root cause | Use error |
| Action | Ormco Corporation initiated this recall by sending recall letters to customers on March 25, 2014 via 1st class mail. The letter identified the affected product, problem and actions to be taken. The consignees are instructed to complete the "Return Form" and return any affected product in their inventory. The letter was written in Japanese language and accompanied by a "Return Form". |
| Quantity | 150 units |
| Distribution | Internationally Distributed in the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943245 | SPIRIT MB Sybron Dental Specialties, Inc., Aug 23, 1994 |