WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
FDA device recall Z-1671-2025 · posted 2025-04-24 · Open, Classified
Recall details
- Recalling firm
- Straumann USA LLC
- Reason for recall
- Incorrect blister labelling.
- Action taken
- 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 included in the notification.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 1,786 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.
- Date initiated
- 2025-04-17
- Date posted
- 2025-04-24
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Straumann® Anatomic Healing Abutments XC (AHA) (K241575) | Straumann USA, LLC | 2024-11-11 |