FDA Medical Device Recalls (openFDA)
BioHorizons Implant Systems Inc: Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
- Recall number
- Z-0801-2007
- Recalling firm
- BioHorizons Implant Systems Inc
- Product
- Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
- Status
- Terminated
- Initiated
- 2007-04-18
- Posted
- 2007-05-11
- Terminated
- 2007-08-11
- Reason
- Dental implant system is missing ball attachment system.
- Root cause
- Other
- Action
- Letters explaining the problem and MBAS systems were sent via United Parcel Service (UPS) 3rd day package delivery to the consignees (both domestic and abroad) on 04/18/2007.
- Quantity
- 34 units
- Distribution
- Worldwide distribution ---- USA and country of Italy
- Lot, serial or model codes
- Lot No. S0207053
- 510(k) numbers
- ["K041938"]
- PMA numbers
- not on file
- Product code
- DZE
- 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