Straumann USA LLC recalls WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

Incorrect blister labelling.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1671-2025
• FDA 510(k) clearance · K241575The device's official FDA premarket clearance record
• FDA device classification · NHAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3630The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Straumann USA LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.