Z-1994-2026Class II

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant...

Name: Z-1994-2026 Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant...
Creator: Straumann USA LLC
Published: 2026-03-27
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2026-03-27 / Open, Classified

FDA source

Straumann USA LLC began a recall of Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments on 2026-03-27. FDA classified it as Class II and gives the reason as "Includes an incorrect screw seat interface". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1994-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-27
Posted: 2026-04-29
Recalling firm: Straumann USA, LLC
Product: Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Includes an incorrect screw seat interface.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 5 units
Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1994-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1994-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29
Z-1995-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code NHA

K242686Class IINeodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A. / cleared 2024-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)