S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
FDA device recall Z-1703-2010 · posted 2010-05-27 · Terminated
Recall details
- Recalling firm
- 3m Imtec Corporation
- Reason for recall
- Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.
- Action taken
- IMTEC notified consignees by phone on May 14, 2010 and by Certified Letter dated May 14, 2010.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 189 Implants
- Distribution
- Nationwide.
- Date initiated
- 2010-05-14
- Date posted
- 2010-05-27
- Date terminated
- 2010-07-14
- Location
- Ardmore, OK
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX (K031106) | Imtec Corp. | 2003-08-12 |