Keystone Dental Recalls Paltop Surgical Kits with Oversized Hex Drivers
Keystone Dental Inc is recalling 13 Paltop Premium Surgical Kits because the 1.25mm Hex Drivers 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, but the source text describes a functional defect (difficulty engaging screws) without reporting any injuries, illnesses, or hospitalizations, aligning with the 'Moderate' criteria for low-risk issues or voluntary precautionary actions.
Plain-English summary
Keystone Dental Inc is recalling 13 Paltop Premium Surgical Kits (Part Number: 60-70112) that contain 1.25mm Hex Drivers. The recall is due to a defect where the hex driving feature may be slightly oversized. This issue makes it difficult to engage screws and abutments containing the corresponding screw feature.
The affected kits are identified by Lot Numbers WO-010252 and WO-010136. The products were distributed in Florida, Massachusetts, South Carolina, and Virginia. These kits are intended for surgical and restorative applications for prosthetic devices, such as artificial teeth.
Consumers and healthcare providers with these specific kits should stop using the 1.25mm Hex Drivers and contact Keystone Dental Inc for instructions on how to proceed.
The recalled product
- Product
- 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
- Manufacturer
- Keystone Dental Inc
- Hazard
- Affected units
- 13
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 (2)
- Lot Numbers: WO-010252
- WO-010136
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
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See all →- ModerateKeystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue
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