LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,
FDA device recall Z-0665-03 · posted 2003-03-20 · Terminated
Recall details
- Recalling firm
- Implant Innovations, Inc.
- Reason for recall
- Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
- Action taken
- The firm faxed a recall notification to their accounts on 1/28/2003. Consignees were requested to subrecall to the user/health professional level and respond. Also they were requested to provide disposition information.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 68
- Distribution
- Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile.
- Date initiated
- 2003-01-28
- Date posted
- 2003-03-20
- Date terminated
- 2012-05-03
- 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 STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM) (K950204) | Implant Innovations, Inc. | 1995-09-27 |