Recall Z-1671-2025— Straumann USA LLC

Name: FDA recall Z-1671-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-17

Class II · Ongoing

Class II FDA medical device recall by Straumann USA LLC, initiated 2025-04-17. It names one FDA 510(k) clearance: K241575. Product: WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.. Reason: Incorrect blister labelling..

Recalling firm: Straumann USA LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-04-17
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K241575 — Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC·cleared 2024-11-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Incorrect blister labelling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.