FDA Device recall Z-1994-2026
Straumann n!ce PMMA Full-arch Restoration
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Straumann n!ce PMMA Full-arch Restoration by Straumann Usa, citing includes an incorrect screw seat interface.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1994-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-27 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Straumann Usa |
| Distribution | AL, AZ, FL, HI, LA, MD, OH, VA |
Product
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Reason
Includes an incorrect screw seat interface.
Identifiers
| code_info | Article 010.0304. UDI: (01)07630031779977(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00811_00_b00, 28000US_00811_01_b…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1994-2026%22
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