FDA Medical Device Recalls (openFDA)
Dentsply Friadent Ceramed: XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant)
- Recall number
- Z-0231-2007
- Recalling firm
- Dentsply Friadent Ceramed
- Product
- XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant)
- Status
- Terminated
- Initiated
- 2006-11-17
- Posted
- 2006-12-01
- Terminated
- 2007-04-30
- Reason
- Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
- Root cause
- Other
- Action
- Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product.
- Quantity
- 1685 units
- Distribution
- Worldwide-USA and one Canadian consignee.
- Lot, serial or model codes
- Model # 26-0123
- 510(k) numbers
- ["K032750"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1721411
- Firm city
- Lakewood
- Firm state
- CO
- 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