FDA recall Z-1671-2025

Straumann USA LLC · Class II · device

Product

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

Reason for recall

Incorrect blister labelling.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-04-17
Report date
2025-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1671-2025