Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Garden
FDA device recall Z-0128-2008 · posted 2008-01-17 · Terminated
Recall details
- Recalling firm
- Biomet 3i
- Reason for recall
- Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.
- Action taken
- Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 114
- Distribution
- Worldwide Distribution - USA, Italy, France, Spain and UK.
- Date initiated
- 2007-10-08
- Date posted
- 2008-01-17
- Date terminated
- 2008-07-10
- 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 |
|---|---|---|
| PREFORMANCE TEMPORARY CYLINDER (K060291) | Implant Innovations, Inc. | 2006-02-27 |