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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/Implants & Prosthetics

Inclusive Titanium Screws Recalled for Incorrect Component Packaging

Agency Publication Date: November 3, 2025
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Summary

Prismatik Dentalcraft, Inc. has recalled 208 units of Inclusive Titanium Screws compatible with Biomet 3i Certain dental implants (3.4, 4.1, 5.0, and 6.0 mm sizes). The recall was issued because an incorrect titanium screw was packaged inside the dental implant kits. Healthcare providers should contact the manufacturer or their distributor to arrange for a return, replacement, or correction of the affected units.

Risk

Using the incorrect screw during a dental procedure could result in an improper fit, mechanical failure of the implant, or the need for additional corrective surgery.

What You Should Do

  1. This recall involves Inclusive Titanium Screws compatible with Biomet 3i Certain 3.4/4.1/5.0/6.0 mm dental implants.
  2. Check your inventory for Product Catalog Number (SKU) 70-1047-COM0117 with Lot Numbers 6270484 or 6271089.
  3. Identify affected products by the UDI code +D745701047COM01170/$$80176270484/16D20250722E found on the packaging.
  4. Stop using the recalled device immediately. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Inclusive Titanium Screw compatible with: Biomet 3i Certain
Variants: 3.4 mm, 4.1 mm, 5.0 mm, 6.0 mm
Model / REF:
70-1047-COM0117
Lot Numbers:
6270484
6271089
UDI:
+D745701047COM01170/$$80176270484/16D20250722E

Incorrect titanium screw packaged with dental implant.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97720
Status: Active
Manufacturer: Prismatik Dentalcraft, Inc.
Sold By: Authorized dental distributors
Manufactured In: United States
Units Affected: 208 units
Distributed To: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, 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.