Ormco/Sybronendo: Medical Device Recall in 2015 - (Recall #: Z-0343-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 4, 2015

Date Posted: December 9, 2015

Recall Number: Z-0343-2016

Event ID: 72590

Reason for Recall:

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

Status: Terminated

Product Quantity: 161 units

Code Information:

Lot No. 21538339

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated