FDA DevicesClass II
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous De...
Published: May 6, 2026Recall ID: Z-1995-2026Category: devicesCountry: US
Reason for Recall / Hazard
Includes an incorrect screw seat interface.
Product Description & Identification
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Affected Products
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Additional Source Details
| Field | Value |
|---|---|
| City | Andover |
| State | MA |
| Event id | 98681 |
| Address 1 | 60 Minuteman Rd |
| Code info | 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. |
| Postal code | 01810-1008 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 6 units |
| Reason for recall | Includes an incorrect screw seat interface. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260327 |
| Initial firm notification | Letter |
| Center classification date | 20260429 |
Overview
- Recalling FirmStraumann USA LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS distribution to AL, AZ, FL, HI, LA, MD, OH, VA.