Z-1337-2026 Class III Ongoing
FDA device recall Z-1337-2026 was initiated by Straumann USA LLC on January 6, 2026 and is designated Class III. Reason for recall: The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. The recall status is ongoing. Affected quantity: 561 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2026
- Initiation Date
- January 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 561 units
Product Description
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Reason for Recall
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Distribution Pattern
US Nationwide distribution.
Code Information
Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;