Recall Z-1063-2019 ยท DZE Implant, Endosseous, Root-Form
Keystone Dental Inc
Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
| Date | Feb 22, 2019 |
| Status | Terminated |
| Reason | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature |
| Root cause | Process control |
| Action | Keystone Dental initiated recall by phone to each one of the impacted customers. The phone call was then followed by a Recall Notification Letter that was mailed via overnight FedEx mail on February 22, 2019. Letters states problem and action to take: Replacement 1.25mm Hex Driver(s) have been provided to you with this letter. The 1.25mm Hex Driver(s) currently in your kit should be discarded. Please refer to the images on page 2 to locate the driver within your kit. This issue is limited to this 1.25mm Hex Driver(s) only and no other product within the kit is affected by this issue. Complete |
| Quantity | 3 hex Driver |
| Distribution | FL, MA, SC, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112795 | PALTOP DENTAL IMPLANT SYSTEM Paltop Advanced Dental Solutions, Ltd., Apr 20, 2012 |