Recalls / —

—#218079

Product

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

FDA product code: NDP — Accessories, Implant, Dental, Endosseous
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On January 6, 2026 Urgent Field Safety Action letters were sent to customers. Actions to be taken: 1. Check your inventory for the affected article/lot numbers. 2. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. 3. Please return the affected items to the attention of Jennifer Jackson at Straumann USA, LLC for replacement as indicated on the Customer Confirmation Form. 4. If you have used the WB Impression Post Closed Tray, no action regarding patient treatment is required. 5. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to jennifer.jackson@straumann.com This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred.

Recalling firm

Firm: Straumann USA LLC
Address: 60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2026-01-06
Posted by FDA: 2026-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218079. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.