Z-0639-2012

TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and

Name: Z-0639-2012 TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and
Creator: Ormco Corporation
Published: 2011-03-15
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2011-03-15 / Terminated / root cause: packaging

FDA source

Ormco Corporation began a recall of TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic... on 2011-03-15. The reason FDA records is "The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0639-2012
Status: Terminated
Initiated: 2011-03-15
Posted: 2012-01-11
Terminated: 2012-03-08
Recalling firm: Ormco/Sybronendo
Product: TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment.
Product code: DZC Wire, Orthodontic
Reason for recall: The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007.
Root cause tag: packaging
FDA root cause: Packaging
Action: Ormco Corporation sent a Urgent Medical Device Recall letter dated April 29, 2011, to the customers in the United States and Canada via USPS First Class mail. The recall letter for customers in Europe are being translated. Ormco Corporation sent the recall letter dated May 20, 2011, to the customers in Austrailia. The letter identified the product the problem and the action needed to be taken by the customer. As a result of this situation the customer is instructed to return the affected lot number of product. This will be replaced at no charge or credited to account. Please label your returned product " RECALLED PRODUCT" attention Customer Return. In addition, we ask for your assistance in completing the RETURN FORM and returning it by fax 909-962-5605.
Quantity in commerce: 23 Packs
Distribution: Worldwide Distribution -- USA including the states of Indiana and Minnesota; and the countries of Canada, Europe and Australia.
Product codes and lots: Part Number: 211-1402; Lot Number: 10K291

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)