Premier Solo Diamond dental burs recalled due to material hardness defect
Premier Dental Products Co is recalling Premier Solo Diamond Large dental burs because the material hardness does not meet specifications and may cause the burs to bend during use. 77 units in six U.S. states are affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a material specification defect. The defect presents a risk of harm to dental patients through potential bur bending during use, but no injuries have been reported in the source material.
Plain-English summary
Premier Dental Products Co is recalling Premier Solo Diamond - Large Invented Cone dental burs (SKU: 807016C, UDI-DI: 00348783000237). The burs were distributed in California, Minnesota, New York, Pennsylvania, Tennessee, Virginia, and Washington.
The recalled dental burs have material hardness that does not meet the manufacturer's specifications. This defect may cause the burs to bend during clinical use, which could compromise dental procedures and pose a risk to patient safety.
The affected lot numbers are M0117646, M0120260, and M0123294. A total of 77 units were distributed.
If you have received or are using these dental burs, stop using the product immediately and contact Premier Dental Products Co. Follow the manufacturer's instructions for handling and disposal of the affected units.
The recalled product
- Product
- Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
- Manufacturer
- Premier Dental Products Co
- Hazard
- Affected units
- 77
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 (5)
- SKU: 807016C
- UDI-DI: 00348783000237
- Lot Numbers: M0117646
- M0120260
- M0123294
Distribution
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