Recall Z-1337-2026— Straumann USA LLC

Name: FDA recall Z-1337-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-06

Class III · Ongoing

Class III FDA medical device recall by Straumann USA LLC, initiated 2026-01-06. FDA's recall record names no specific 510(k) clearance for this event. Product: WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM. Reason: The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown..

Recalling firm: Straumann USA LLC
Classification: Class III
Status: Ongoing
Initiated: 2026-01-06
Firm location: Andover, MA, United States

Product description

WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

Reason for recall

The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.

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