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Recall Observatory FDA recall evidence

Device product

Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

Z-0343-2016

November 04, 2015

Class II

Product summary

Firm
Ormco/Sybronendo
Event
Event 72590
Status
Terminated
Classification
Class II
Quantity
161 units
Official record key
device-enforcement:Z-0343-2016

Official wording

Reason: Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.

Code information: Lot No. 21538339

Distribution pattern: Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling is incorrect