Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are i
FDA device recall Z-0299-2017 · posted 2016-10-21 · Terminated
Recall details
- Recalling firm
- Keystone Dental Inc
- Reason for recall
- Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
- Action taken
- Keystone Dental initially called all customers on September 15, 2016. Forms were completed to document these calls. In addition a letter has been sent via Federal Express/or hand delivered on September 19, 2016, to all distributors and customers. Customers with questions were instructed to contact Customer Relations. For questions regarding this recall call 781-328-3390.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 55 units
- Distribution
- Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
- Date initiated
- 2016-09-15
- Date posted
- 2016-10-21
- Date terminated
- 2017-01-03
- 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 |