TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this d

FDA device recall Z-0639-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Ormco Corporation

Reason for recall

The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007.

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

DZC

Quantity affected

23 Packs

Distribution

Worldwide Distribution -- USA including the states of Indiana and Minnesota; and the countries of Canada, Europe and Australia.

Date initiated

2011-03-15

Date posted

2012-01-11

Date terminated

2012-03-08

Location

Glendora, CA