WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
FDA Recall Z-1337-2026 · Posted 2026-02-09
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Recalling FirmStraumann USA LLC
Recall StatusOpen, Classified
Product CodeNDP
Date Initiated2026-01-06
Product Quantity561 units
Reason for Recall
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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