FDA Medical Device Recalls (openFDA)
BioHorizons Implant Systems Inc: The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm
- Recall number
- Z-0925-05
- Recalling firm
- BioHorizons Implant Systems Inc
- Product
- The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm
- Status
- Terminated
- Initiated
- 2005-06-03
- Posted
- 2005-06-23
- Terminated
- 2005-08-11
- Reason
- The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement.
- Root cause
- Other
- Action
- The domestic consignees were contacted by telephone on 06/03/2005 to request the return of the products. The foreign consignee was contacted via telephone and email to request the same action.
- Quantity
- 5 units
- Distribution
- PA, TX, MI, VA and Russia
- Lot, serial or model codes
- Lot No. C0205048
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDP
- Firm FEI
- 1000592496
- Firm city
- Birmingham
- Firm state
- AL
- 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