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Recall Observatory FDA recall evidence

Device product

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

Z-1337-2026

January 06, 2026

Class III

Product summary

Firm
Straumann USA LLC
Event
Event 98265
Status
Ongoing
Classification
Class III
Quantity
561 units
Official record key
device-enforcement:Z-1337-2026

Official wording

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

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

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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