Recall Z-0120-2013— Ormco/Sybronendo
Class III · Terminated
Class III FDA medical device recall by Ormco/Sybronendo, initiated 2012-04-24, terminated 2012-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.. Reason: The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets..
- Recalling firm
- Ormco/Sybronendo
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-04-24
- Terminated
- 2012-12-12
- Firm location
- Glendora, CA, United States
Product description
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Reason for recall
The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets.
Data sourced from openFDA. This site is unofficial and independent of the FDA.