Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc.,
FDA device recall Z-0801-2007 · posted 2007-05-11 · Terminated
Recall details
- Recalling firm
- BioHorizons Implant Systems Inc
- Reason for recall
- Dental implant system is missing ball attachment system.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 34 units
- Distribution
- Worldwide distribution ---- USA and country of Italy
- Date initiated
- 2007-04-18
- Date posted
- 2007-05-11
- Date terminated
- 2007-08-11
- Location
- Birmingham, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXIMUS OS (OVERDENTURE SYSTEM) (K041938) | BioHorizons Implant Systems, Inc. | 2004-07-22 |