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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Premier Solo Diamond Dental Burs Recalled for Potential Bending Risk

Agency Publication Date: March 21, 2025
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Summary

Premier Dental Products Co is recalling 77 units of Premier Solo Diamond dental burs (Large Invented Cone) because the material hardness does not meet specifications. This defect can cause the diamond bur to bend during a dental procedure. The recall affects products with SKU 807016C and specific lot numbers sold through dental product distributors.

Risk

If the dental bur bends during use, it could cause injury to the patient or dental professional, or lead to inaccurate clinical results.

What You Should Do

  1. This recall involves Premier Solo Diamond dental burs (Large Invented Cone), SKU 807016C, with lot numbers M0117646, M0120260, and M0123294.
  2. Stop using the recalled dental burs immediately and remove them from your clinical inventory.
  3. Contact Premier Dental Products Co or your dental product distributor to arrange for the return, replacement, or correction of the affected products.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer safety questions.

Your Remedy Options

๐Ÿ“‹Other Action

Return, replacement, or correction.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Premier Solo Diamond - Large Invented Cone
Model / REF:
807016C
Lot Numbers:
M0117646
M0120260
M0123294
UDI:
00348783000237

Recall quantity: 77 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96394
Status: Active
Manufacturer: Premier Dental Products Co
Sold By: Dental product distributors
Manufactured In: United States
Units Affected: 77 units
Distributed To: California, Minnesota, New York, Pennsylvania, Tennessee, Virginia, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.