Z-0343-2016Class II

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

Name: Z-0343-2016 Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide...
Creator: Ormco/Sybronendo
Published: 2015-11-04
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2015-11-04 / Terminated / root cause: manufacturing process

FDA source

Ormco/Sybronendo began a recall of Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement on 2015-11-04. FDA classified it as Class II and gives the reason as "Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0343-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-04
Posted: 2015-11-30
Terminated: 2016-01-19
Recalling firm: Ormco/Sybronendo
Product: Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Product code: DZC Wire, Orthodontic
Reason for recall: Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: A recall letter dated 11/5/15 was sent to all their customers who purchased the Copper NiTi Preformed Archwires because it has been brought to Ormco's attention that the product transformation temperature as listed on the labeling is incorrect. The wire is labeled as having 40 degrees Celsius transformation temperature, but the actual wire has a transformation temperature of 29 degrees Celsius. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form.
Quantity in commerce: 161 units
Distribution: Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
Product codes and lots: Lot No. 21538339

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0343-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0343-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30

Product code DZC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)