SPI EASY Abutment. Endosseous dental implant abutment.
FDA device recall Z-1086-2007 · posted 2007-07-24 · Terminated
Recall details
- Recalling firm
- Thommen Medical, AG
- Reason for recall
- The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.
- Action taken
- Letter 5/14/2007. Customers are requested to check their current inventory for the recall product. If found they are to return the product for replacement. If they have implanted the product they are to check patient x-rays for the defect. If defects are found they are to do a restoration.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 84
- Distribution
- Nationwide.
- Date initiated
- 2007-04-19
- Date posted
- 2007-07-24
- Date terminated
- 2008-05-12
- Location
- Waldenburg, Switzerland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPI EASY DENTAL IMPLANT ABUTMENT (K023645) | Thommen Medical AG | 2002-11-13 |