FDA Medical devices recall ·
WB Impression Post Closed Tray incl recall
- Recall number
- Z-1337-2026
- Date
- (initiated January 6, 2026)
- Company / brand
- Straumann USA LLC
60 Minuteman Rd, Andover, MA, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 561 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Why was it recalled?
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
Distribution
US Nationwide distribution.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-1337-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.