WB Impression Post Closed Tray incl. guide screw, L 13mm… recallZ-1337-2026 · Straumann USA LLC · initiated Jan 6, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] 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.
Recall details
- Recall number
- Z-1337-2026
- Status
- Open, Classified
- Initiated by the company
- Jan 6, 2026
- Posted by the FDA
- Feb 9, 2026
- Recalling firm
- Straumann USA LLC
- Quantity
- 561 units
- Product code
- NDP
- Distribution
- US Nationwide distribution.
Product description
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Code information (models, lots, serial numbers)
Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA Conventional impressionInstitut Straumann AG · Accessories, implant, dental, endosseous1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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