Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.
FDA device recall Z-1221-2007 · posted 2007-09-18 · Terminated
Recall details
- Recalling firm
- Biomet 3i
- Reason for recall
- The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.
- Action taken
- International customers were contacted first by e-mail , then by fax letter 08/03/2007.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 240 (120 each model / lot)
- Distribution
- Product was not distributed within the U.S. Product was distributed Internationally - Brazil, Argentina, Israel, Mexico, Colombia, Korea, Taiwan, Uruguay, Italy, Chile.
- Date initiated
- 2007-08-03
- Date posted
- 2007-09-18
- Date terminated
- 2009-09-11
- 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 |
|---|---|---|
| OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE (K063286) | Implant Innovations, Inc. | 2007-04-24 |
| 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM) (K950204) | Implant Innovations, Inc. | 1995-09-27 |