Straumann n!ce PMMA Full-arch Restoration. Screw-retained… recallZ-1994-2026 · Straumann USA LLC · initiated Mar 27, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Includes an incorrect screw seat interface.
FDA root cause category: Under Investigation by firm
What the company is doing
Straumann USA notified consignees on about 03/27/2026 via telephone call, mailed letter, or email. Consignees were instructed to examine inventory for affected product, cease use and quarantine any affected units on hand, arrange for the return of all affected units and complete and return the provided Customer Confirmation Form. Consignees were also instructed to no contact Straumann contact Jennifer Jackson to organize a remake of the units, if any were used. Once the new restoration is available, schedule the patient to replace the restoration.
Recall details
- Recall number
- Z-1994-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 27, 2026
- Posted by the FDA
- Apr 29, 2026
- Recalling firm
- Straumann USA LLC
- Quantity
- 5 units
- Product code
- NHA
- FDA submissions
- K242686
- Distribution
- US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Product description
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Neodent Implant System Bridges (tooth borne)Institut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98681).
- Z-1995-2026 · Open, ClassifiedStraumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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