RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
FDA device recall Z-0975-05 · posted 2005-07-07 · Terminated
Recall details
- Recalling firm
- Straumann Manufacturing Inc
- Reason for recall
- Basal screw is too short to adequately hold the dental abutment in the implant
- Action taken
- Straumann USA initiated the recall by letter dated 6/6/05. Users are requested to return devices and to examine patients with the implanted device.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 23
- Distribution
- AZ, CA, DE, FL, NY, OH, OK, TX
- Date initiated
- 2005-06-06
- Date posted
- 2005-07-07
- Date terminated
- 2005-11-03
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM (K020096) | Institut Straumann AG | 2002-02-08 |