Paltop Dental Implant Recall Due to Incorrect Cover Screw Packaging
Paltop Advanced Dental Solutions is recalling 67 dental implants because some were packaged with the wrong cover screw, preventing proper fit.
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. The hazard is a functional defect (incorrect screw fit) rather than a direct health risk like infection or injury, and no illnesses or injuries are reported in the source text.
Plain-English summary
Paltop Advanced Dental Solutions Ltd is recalling 67 units of the Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm (Catalog Number 21-70020). The recall is due to a packaging error where some implants were shipped with a Standard Platform Cover Screw instead of the required Narrow Platform Cover Screw.
The incorrect Standard Platform Cover Screw will not fit into the Narrow Platform implant. This defect prevents the proper assembly of the dental implant system. The affected products were distributed to dental professionals in California, the District of Columbia, Florida, Georgia, Massachusetts, Maryland, New Jersey, New York, South Carolina, Texas, and Virginia.
The specific lot number is WO-011320, and the UDI is 07290108695649. Consumers and dental professionals should stop using these specific implants and contact the manufacturer for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
- Manufacturer
- Paltop Advanced Dental Solutions Ltd
- Category
- Medical Device — Dental Implants
- Affected units
- 67
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)
- UDI: 07290108695649
- Lot Number WO-011320
Distribution
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