Straumann USA LLC: Device Recall

Recall #Z-1671-2025 · 04/17/2025

Class II: Risk

Recall Details

Recall Number: Z-1671-2025
Classification: Class II
Product Type: Device
Recalling Firm: Straumann USA LLC
Status: Ongoing
Date Initiated: 04/17/2025
Location: Andover, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,786 units

Reason for Recall

Incorrect blister labelling.

Product Description

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

Distribution Pattern

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

Other Recalls by Straumann USA LLC

Class II: Risk 10/17/2025

The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Class II: Risk 05/01/2025

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Class II: Risk 05/01/2025

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Class II: Risk 04/14/2025

The referred batch was produced without the laser engraving of 7 mm.
Class II: Risk 03/08/2025

The devices are missing the laser marked depth markings.

View all recalls by Straumann USA LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.