Ortho Organizers, Inc.: 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)8

Is my product affected?

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

• UPC 00190707017064
• UPC 00190707017071

Check against the official notice below — it lists the full affected range.

What happened

Ortho Organizers, Inc. is recalling Maestro Orthodontic Bracket products due to mislabeling. The recall involves 147 kits distributed to 13 consignees in the United States (Florida, Georgia, California, Michigan, Idaho, and Texas) as well as international locations including Italy, Japan, Greece, Saudi Arabia, Russia, and the Czech Republic. The affected products are Maestro Orthodontic Bracket .018 Kit U/L SxS with part numbers 711-298Q (Lot# 878285) and 711-299MCQ with MC Hooks (Lot# 872900).

The recall record does not specify a remedy or recommended action for consumers who may have received these products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Orthodontic Bracket is mislabeled

Details from the source

Reason for recall: Orthodontic Bracket is mislabeled Distribution: 13 US Consignees in FL, GA, CA, MI, ID, TX 1 = Italy 1 = Japan 1 = Greece 1 = Saudi Arabia 1 = Russia 1 = Czech Republic Quantity: 147 kits Lot/code info: Maestro Orthodontic Bracket ,.018 Kit U/L SxS P/N711-298Q (01)00190707017064 (10)889437 (422)484 Lot# 878285 Maestro Orthodontic Bracket .018 Kit U/L SxS MC Hooks P/N711-299MCQ UDI (01)00190707017071(10)889437 (422)484 Lot#872900

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 2560552019-04-03
• Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.2019-04-03
• TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)2019-04-05
• Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System2019-03-30
• Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 008130240132662019-03-30

All FDA (Device enforcement) recalls