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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

Straumann n!ce Dental Implant Restorations Recalled for Incorrect Screw Seat

Agency Publication Date: April 29, 2026
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Summary

Straumann USA LLC is recalling 11 units of its n!ce PMMA and Zr HT full-arch dental restorations because they were manufactured with an incorrect screw seat interface. This defect affects the way the dental bridge or abutment attaches to the implant, potentially leading to fitting issues. These products were distributed to dental professionals and clinics in eight states including Alabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio, and Virginia. Consumers who have received these specific dental implants should contact their healthcare provider or dentist to discuss the next steps for evaluation and correction.

Risk

The incorrect screw seat interface can prevent the dental restoration from properly securing to the implant, which may cause the prosthetic to become loose or fail. While no specific injuries were reported in this notice, a failing dental implant component can lead to discomfort, damage to surrounding tissue, or the need for additional corrective dental procedures.

What You Should Do

  1. Identify if your dental restoration is affected by checking your patient records or product documentation for Article Numbers 010.0304 or 010.0158. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately if you are a dental professional. Patients who suspect they have an affected restoration should contact their dentist or oral surgeon.
  3. Contact Straumann USA LLC or your dental distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

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: Straumann n!ce PMMA Full-arch Restoration Screw-retained Bridge
Variants: PMMA, Full-arch Restoration, Screw-retained Bridge
Model / REF:
010.0304
Serial Numbers:
28000US_00811_00_b00
28000US_00811_01_b00
28000US_00426_00_b00
28000US_00449_00_b00
28000US_01266_00_b00
UDI:
07630031779977

Endosseous Dental Implant Abutments

Product: Straumann n!ce Zr, HT, Full-arch Restoration
Variants: Zirconia (Zr), High Translucency (HT), Full-arch Restoration
Model / REF:
010.0158
Serial Numbers:
28000US_00622_00_b00
28000US_00431_00_b00
28000US_00489_00_b00
28000US_00792_00_b00
28000US_00908_00_b00
28000US_00908_01_b00
UDI:
07630031759764

Endosseous Dental Implant Abutments

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98681
Status: Active
Manufacturer: Straumann USA LLC
Sold By: Dental clinics; Oral surgery centers; Straumann authorized distributors
Manufactured In: United States
Units Affected: 11
Distributed To: Alabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio, Virginia

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.