Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:27459
Brand Name:Spark Aligner
Model:
Affected:PDF report
Software version:
Recalling Organisation:Law and Accounting Professional Trustees Limited
336, Jackson Street
Petone
Contact Information:04 566 2853
Manufacturer:Ormco Corporation
Issue:It has recently come to the manufacturer attention that in a few select cases, the PDF report shipped with the Spark product contains an error. The stage that inter proximal reduction (IPR) was to be performed as shown on the printed PDF was incorrectly listed as one stage later than what was correctly presented in the Approver software. Please discard the printed PDF report on the affected cases and instead use the PDF report which can be generated through the Spark Approver Software.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Healthcare Professional
Date Commenced:17/3/2021
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