FDA Medical Device Recalls (openFDA)
Ormco Corporation: 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.
- Recall number
- Z-0639-2012
- Recalling firm
- Ormco Corporation
- 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.
- Status
- Terminated
- Initiated
- 2011-03-15
- Posted
- 2012-01-11
- Terminated
- 2012-03-08
- Reason
- The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007.
- 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
- 23 Packs
- Distribution
- Worldwide Distribution -- USA including the states of Indiana and Minnesota; and the countries of Canada, Europe and Australia.
- Lot, serial or model codes
- Part Number: 211-1402; Lot Number: 10K291
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DZC
- Firm FEI
- 2016150
- Firm city
- Glendora
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28