Drug recall
Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
FDA recall event 82374 · Class II · Keystone Dental Inc
Key facts
| Event ID | 82374 |
|---|---|
| Recall numbers | Z-1061-2019, Z-1062-2019, Z-1063-2019, Z-1064-2019 |
| Recalling firm | Keystone Dental Inc |
| Product type | Devices |
| Products | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101, Paltop 1.25 Hex Drivers, Short Part Number: 60-70102, Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021, Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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 |
| Initiation date | Feb 22, 2019 |
| Report date | Apr 3, 2019 |
| Termination date | Jun 19, 2020 |
| City | Burlington |
| State | MA |
| Country | United States |
| FEI number | 3005990499 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: