Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
FDA device recall Z-1818-2017 · posted 2017-04-13 · Terminated
Recall details
- Recalling firm
- Keystone Dental Inc
- Reason for recall
- Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
- Action taken
- Keystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 59 units
- Distribution
- CA, IL, IN, FL, MA, MN, NJ, NV, PA,
- Date initiated
- 2017-03-09
- Date posted
- 2017-04-13
- Date terminated
- 2017-07-05
- Location
- Burlington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS (K051614) | Lifecore Biomedical, Inc. | 2005-09-09 |