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Open, Classified

WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

FDA Recall Z-1671-2025 · Posted 2025-04-24

Recalling FirmStraumann USA LLC
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2025-04-17
Product Quantity1,786 units

Reason for Recall

Incorrect blister labelling.

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 included in the notification.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC · 2024-11-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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