BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioM
FDA device recall Z-1365-2008 · posted 2008-03-28 · Terminated
Recall details
- Recalling firm
- Biomet 3i, Inc.
- Reason for recall
- Seating Problems: The Micro-miniplant Straight Healing Abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.
- Action taken
- USA customers were contacted by telephone with a follow-up fax. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 270
- Distribution
- Worldwide
- Date initiated
- 2008-02-06
- Date posted
- 2008-03-28
- Date terminated
- 2008-07-07
- 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 |
|---|---|---|
| BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS (K072642) | Biomet 3i, Inc. | 2007-12-20 |