FDA-Device2026-02-18Class III

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

Straumann USA LLC
Hazard
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Sold states
US Nationwide distribution.
Affected count
561 units
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

Official notice

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

Original summary

WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6; Distribution: US Nationwide distribution. Affected quantity: 561 units

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