FDA recall Z-1337-2026

Straumann USA LLC · Class III · device

Product

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-01-06
Report date
2026-02-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1337-2026