Recall Z-2478-2020— Ortho Organizers, Inc.
Class II · Terminated
Class II FDA medical device recall by Ortho Organizers, Inc., initiated 2019-04-02, terminated 2022-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484. Reason: Orthodontic Bracket is mislabeled.
- Recalling firm
- Ortho Organizers, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-02
- Terminated
- 2022-03-24
- Firm location
- Carlsbad, CA, United States
Product description
Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
Reason for recall
Orthodontic Bracket is mislabeled
Data sourced from openFDA. This site is unofficial and independent of the FDA.