Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0639-2012 · Posted 2012-01-11

Recalling FirmOrmco Corporation
Recall StatusTerminated
Product CodeDZC
Date Initiated2011-03-15
Date Terminated2012-03-08
Product Quantity23 Packs

Reason for Recall

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

Firm 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.

Root Cause

Packaging

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑