Premier Solo Diamond - Large Invented Cone Recall: Diamond Bur May Bend
Premier Dental Products recalls Premier Solo Diamond - Large Invented Cone (SKU 807016C) due to hardness issues that may cause the diamond bur to bend. Affected units include specific lot numbers and UDI-DI.
Lower-risk recall
The hardness not meeting the material specification and may cause the diamond bur to bend.
Contact the company
What happened, in plain English
Premier Dental Products is recalling their Premier Solo Diamond - Large Invented Cone (SKU 807016C) because the diamond bur may bend due to hardness not meeting material specifications. This could affect dental procedures and requires checking the lot numbers and UDI-DI. Read more at govinfonow.com/recall/52736-premier-solo-diamond-large-invented-cone-recall-diamond-bur-may.
Source Summary by GovInfoNow · govinfonow.com/recall/52736-premier-solo-diamond-large-invented-cone-recall-diamond-bur-may · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1408-2025
Cite this page
“Premier Solo Diamond - Large Invented Cone Recall: Diamond Bur May Bend.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52736-premier-solo-diamond-large-invented-cone-recall-diamond-bur-may. Based on FDA recall #Z-1408-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1408-2025%22&limit=1).
Why it’s dangerous
The diamond bur may bend because the hardness does not meet the required material specifications. This bending could impact the precision of dental procedures and potentially cause damage to the dental equipment or patient safety.
Who’s affected
Dental professionals using the Premier Solo Diamond - Large Invented Cone are likely affected. Those with specific lot numbers M0117646, M0120260, or M0123294 and UDI-DI 00348783000237 are most at risk.
How to tell if you have this one
Check for SKU 807016C on the product. Look for lot numbers M0117646, M0120260, or M0123294 and UDI-DI 00348783000237.
- Brand
Premier Dental Products- Category
Medical device
What to do — step by step
Check Product Details
Identify the SKU (807016C), lot numbers (M0117646, M0120260, M0123294), and UDI-DI (00348783000237) to confirm if your item is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
FDA distribution: “US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Minnesota, New York, Pennsylvania, Tennessee, Virginia, Washington.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1408-2025 (February 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1408-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.