Keystone Dental Recalls Paltop Surgical Kits Due to Oversized Hex Driver
Keystone Dental Inc. is recalling Paltop Fully Guided Surgical Kits because the included 1.25mm Hex Driver may be oversized, making it difficult to engage screws and abutments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text describes a functional defect (difficulty engaging screws) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity recall.
Plain-English summary
Keystone Dental Inc. is recalling the Paltop Fully Guided Surgical Kit, Part Number 30-70021. The recall involves the 1.25mm Hex Driver included in the kit, which is used for surgical and restorative applications for prosthetic devices such as artificial teeth.
The recall was initiated because the hex driving feature of the driver may be slightly oversized. This defect makes it difficult to engage screws and abutments that contain the corresponding screw feature.
The affected product, identified by Lot Number WO-010366, was distributed in Florida, Massachusetts, South Carolina, and Virginia. Consumers and healthcare providers should stop using the affected hex drivers and contact Keystone Dental Inc. for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Keystone Dental Inc
- Hazard
- Affected units
- 1
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 Numbers: WO-010366
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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