The Recall Desk
ModerateFDA (Devices)·Z-1064-2019·Announced 2019-04-03

Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the oversized feature makes 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, which typically indicates a temporary or medically reversible adverse health consequence. The defect causes functional difficulty rather than direct injury, fitting the Moderate severity criteria.

Plain-English summary

Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers, Short (Part Number: 60-70102). The recall involves 3 Hex Drivers from Lot Number WO-010354. The products were distributed in Florida, Massachusetts, South Carolina, and Virginia.

The recall is being issued because the hex drivers may have a slightly oversized hex driving feature. This defect makes it difficult to engage screws and abutments containing the corresponding screw feature.

Consumers 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, Short Part Number: 60-70102
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-010354

Distribution

Distributed in 4 states:

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 →