Summary
The FDA issued a Class III for WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM by Straumann USA LLC. Reason: The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown..
Details
Source
Device Recall
External ID
Z-1337-2026
Action Date
2026-02-18
Status
Ongoing
Category
device
Product Description
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Lot/Code Info: Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
Quantity Affected: 561 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-06
Company
Andover, MA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Straumann USA LLC has 17 FDA actions in our database, including 15 recalls and 2 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Straumann USA LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Straumann USA LLC have FDA actions?
Straumann USA LLC has 17 FDA actions in our database, including 15 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1337-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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