Straumann Dental Implant Abutments Recall: Incorrect Screw Seat Interface
Straumann recalls specific dental implant abutments with an incorrect screw seat interface that could cause improper installation. Affected units include model 010.0158 with UDI codes starting with (01)07630031759764.
Lower-risk recall
Includes an incorrect screw seat interface.
Contact the company
What happened, in plain English
Straumann is recalling certain dental implant abutments due to an incorrect screw seat interface. This could lead to improper installation and potential complications during dental procedures. Read more at govinfonow.com/recall/49584-straumann-dental-implant-abutments-recall-incorrect-screw-seat-interface.
Source Summary by GovInfoNow · govinfonow.com/recall/49584-straumann-dental-implant-abutments-recall-incorrect-screw-seat-interface · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1995-2026
Cite this page
“Straumann Dental Implant Abutments Recall: Incorrect Screw Seat Interface.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49584-straumann-dental-implant-abutments-recall-incorrect-screw-seat-interface. Based on FDA recall #Z-1995-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1995-2026%22&limit=1).
Why it’s dangerous
The abutments have an incorrect screw seat interface, which may cause improper installation during dental procedures. This could lead to complications such as loosening or failure of the implant over time.
Who’s affected
Dental professionals who purchased or use the recalled Straumann n!ce Zr, HT, Full-arch Restoration abutments with model number 010.0158. Patients receiving these implants are at risk if the abutments are improperly installed.
How to tell if you have this one
Check for the model number 010.0158 on the abutments. The unique device identifier (UDI) starts with (01)07630031759764. These units were sold with specific project numbers listed in the recall notice.
- Brand
Straumann- Product
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1994-2026 | Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments; Article 010.0304. UDI: (01)07630031779977(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00811_00_b00, 28000US_00811_01_b00, 28000US_00426_00_b00, 28000US_00449_00_b00, 28000US_01266_00_b00. | 5 units |
| Z-1995-2026 | Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments; Article 010.0158. UDI: (01)07630031759764(11)YYMMDD(10)XXXXX. Project 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. | 6 units |
What to do — step by step
Check Product Details
Verify the model number and UDI code on the abutments to confirm if they are affected.
Where it went and when
Where it was distributed
Distributed in 8 states.
FDA distribution: “US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio, Virginia.
Recall timeline
FDA published this recall 40 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-1995-2026 (March 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1995-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.