Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.
FDA device recall Z-0811-2007 · posted 2007-05-16 · Terminated
Recall details
- Recalling firm
- Biomet 3i
- Reason for recall
- The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
- Action taken
- Each consignee was notified on 4/25/2007 by telephone using a prepared script. A follow letter was sent by fax. Each consignee was instructed to check their respective inventory for the affected product and to return a response card and any affected product to the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 362 units
- Distribution
- Distributed worldwide, including USA, Spain and the Netherlands.
- Date initiated
- 2007-04-25
- Date posted
- 2007-05-16
- Date terminated
- 2008-11-18
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS (K934126) | Implant Innovations, Inc. | 1994-04-25 |