Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue
Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the hex driving feature may be slightly oversized, making it difficult to engage screws and abutments.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a functional defect (oversized feature) that makes engagement difficult, without reported injuries or fatalities.
Plain-English summary
Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers, Long (Part Number: 60-70101). The recall involves 3 hex drivers from Lot Number WO-010352. These products were distributed in Florida, Massachusetts, South Carolina, and Virginia.
The recall was initiated because the hex driving feature on these drivers may be slightly oversized. This defect can make it difficult to engage screws and abutments that contain the corresponding screw feature.
Consumers and healthcare professionals who possess these specific hex drivers should stop using them and contact Keystone Dental Inc for further instructions.
The recalled product
- Product
- Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
- Manufacturer
- Keystone Dental Inc
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: WO-010352
Distribution
Part of a larger recall action
This product is one of 4 recalled by Keystone Dental Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Keystone Dental Inc
See all →- ModerateKeystone Dental Recalls Paltop Surgical Kits Due to Oversized Hex Driver
FDA (Devices) · 2019-04-03
- ModerateKeystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue
FDA (Devices) · 2019-04-03
- ModerateKeystone Dental Recalls Paltop Surgical Kits with Oversized Hex Drivers
FDA (Devices) · 2019-04-03
- ModerateKeystone Dental Recalls Mislabeled Prima Plus Dental Implants
FDA (Devices) · 2018-06-20
- ModerateKeystone Dental Recalls Genesis Surgical Cassettes Due to Burr Wobble
FDA (Devices) · 2018-05-02
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07