FDA Medical Device Recalls (openFDA)
Ormco Corporation: Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020
- Recall number
- Z-0203-06
- Recalling firm
- Ormco Corporation
- Product
- Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020
- Status
- Terminated
- Initiated
- 2005-11-03
- Posted
- 2005-11-26
- Terminated
- 2006-01-11
- Reason
- Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
- Root cause
- Other
- Action
- Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.
- Quantity
- 1560
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number 100512025 and 100512020
- 510(k) numbers
- ["K052477"]
- PMA numbers
- not on file
- Product code
- DYW
- 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