Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
FDA device recall Z-1995-2026 · posted 2026-04-29 · Open, Classified
Recall details
- Recalling firm
- Straumann USA LLC
- Reason for recall
- Includes an incorrect screw seat interface.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 6 units
- Distribution
- US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
- Date initiated
- 2026-03-27
- Date posted
- 2026-04-29
- Location
- Andover, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs (K222836) | Institut Straumann AG | 2023-05-15 |