Recall Z-1671-2025 · NHA Abutment, Implant, Dental, Endosseous
Straumann USA LLC
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
| Date | Apr 24, 2025 (initiated Apr 17, 2025) |
| Status | Open, Classified |
| Reason | Incorrect blister labelling. |
| Root cause | Under Investigation by firm |
| Action | An "Urgent Field Safety Action" notification dated 4/17/2025 was mailed to consignees. The notification instructs consignees to immediately check inventory for affected devices and to quarantine any units identified as in stock. Any recalled devices identified are to be returned to Straumann USA LLC to the attention of Jennifer Jackson for credit or replacement. For affected devices that have been implanted, consignees are being instructed to evaluate the compatibility based on the provided instructions. Consignees are asked to return the provided Customer Confirmation Form using the UPS label |
| Quantity | 1,786 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) Straumann USA, LLC, Nov 11, 2024 |