FDA Enforcement
Class III
Ongoing
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Recall: Z-1337-2026
·
Reported February 18, 2026
Enforcement
- Recall Number
- Z-1337-2026
- Event ID
- 98265
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Straumann USA LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 18, 2026
- Initiation Date
- January 6, 2026
- Classification Date
- February 9, 2026
- Address
- 60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States
Description
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Reason
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Code Info
Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
Distribution
US Nationwide distribution.
Quantity
561 units