Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Straumann WB Impression Post Tray

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Straumann WB Impression Post Traysee related information
Date Initiated by FirmJanuary 06, 2026
Date PostedFebruary 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1337-2026
Recall Event ID 98265
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
ProductWB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Code Information Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactJennifer M. Jackson, MS, RAC
978-747-2509
Manufacturer Reason
for Recall		The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce561 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-