WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Recall
- Recall Number
- Z-1337-2026
- Event Number
- 98265
- Firm
- Straumann USA LLC
- FEI Number
- 1000121052
- Product Code
- NDP
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- January 6, 2026
- Posted
- February 9, 2026
- Address
- 60 Minuteman Rd, Andover, MA, 01810-1008
Description
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
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.
US Nationwide distribution.
561 units