FDA Medical Device Recalls (openFDA)
Ormco/Sybronendo: Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
- Recall number
- Z-0343-2016
- 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.
- Status
- Terminated
- Initiated
- 2015-11-04
- Posted
- 2015-11-30
- Terminated
- 2016-01-19
- Reason
- Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
- 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
- 161 units
- Distribution
- Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
- Lot, serial or model codes
- Lot No. 21538339
- 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