Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain
FDA device recall Z-1828-2012 · posted 2012-06-20 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
- Action taken
- Biomet 3i sent an Urgent: Medical Device Recall letter dated November 04, 2011 via e-mail, facsimile, telephone or postal mail to all consignees affected. The letter identified the affected product, problem and actions to be taken. Each customer was instructed to check their respective inventory for the affected product and return any unused item(s) to Biomet 3i for prompt replacement. For question or concerns contact Biomet 3i at 1-800-342-5454.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 219 units in total
- Distribution
- Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.
- Date initiated
- 2011-11-04
- Date posted
- 2012-06-20
- Date terminated
- 2012-06-25
- 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 |
|---|---|---|
| 3I OSSEOTITE CERTAIN DENTAL IMPLANTS (K063341) | Implant Innovations, Inc. | 2007-04-30 |