Recall Z-1994-2026 · NHA Abutment, Implant, Dental, Endosseous
Straumann USA LLC
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
| Date | Apr 29, 2026 (initiated Mar 27, 2026) |
| Status | Open, Classified |
| Reason | Includes an incorrect screw seat interface. |
| 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 | 5 units |
| Distribution | US distribution to AL, AZ, FL, HI, LA, MD, OH, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242686 | Neodent Implant System Jjgc Indústria E Comércia DE Materiais Dentários S.A., Dec 4, 2024 |