Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
This recall has been terminated (originally issued April 2, 2014).
- Company
- Ormco/Sybronendo
- Recall Initiated
- March 25, 2014
- Posted
- April 2, 2014
- Terminated
- October 27, 2014
- Recall Number
- Z-1321-2014
- Quantity
- 150 units
- Firm Location
- Glendora, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.
Distribution
US and Canada.
Lot / Code Info
Part Number 449-6212, Lot Number 121359169.
Root Cause
Other
Action Taken
Recall notification letters sent to all affected consignees via 1st class mail on March 24, 2014. The consignees are instructed to complete the Return Form and have the option to return any affected product in their inventory to Ormco Corporation. The letter is dated "March 24, 2014" and titled: "URGENT: MEDICAL DEVICE RECALL". The letter informed customers of the recall, reason for recall, product description with part number and lot number, instructions to follow, and contact information. The letter was accompanied by a "Recall Return/Acknowledgement Form".