PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed
FDA device recall Z-0973-2013 · posted 2013-03-20 · Terminated
Recall details
- Recalling firm
- Keystone Dental Inc
- Reason for recall
- Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
- Action taken
- Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NDP
- Quantity affected
- 120 units
- Distribution
- Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
- Date initiated
- 2013-03-11
- Date posted
- 2013-03-20
- Date terminated
- 2013-09-26
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS (K051614) | Lifecore Biomedical, Inc. | 2005-09-09 |