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Z-1337-2026Class III

Straumann USA LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Straumann USA LLC
Product type
Device
Status
Ongoing
Report date
2026-02-18
Distribution
US Nationwide distribution.
Firm state
MA
Product quantity
561 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →