FDA Medical Device Recalls (openFDA)
Ormco Corporation: Titanium Orthos Bracket
- Recall number
- Z-0309-05
- Recalling firm
- Ormco Corporation
- Product
- Titanium Orthos Bracket
- Status
- Terminated
- Initiated
- 2004-11-18
- Posted
- 2004-12-15
- Terminated
- 2005-06-17
- Reason
- Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
- Root cause
- Other
- Action
- Recall letters were mailed from 11/18 thru 11/23. Letters request return of product.
- Quantity
- 6,257
- Distribution
- Nationwide and France, Luxembourg, Spain, Netherlands, Russia, Ireland, Italy, Germany, United Kingdom, Hungary, Finland, Denmark.
- Lot, serial or model codes
- Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJF
- 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