Recall Z-1337-2026 ยท NDP Accessories, Implant, Dental, Endosseous
Straumann USA LLC
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
| Date | Feb 9, 2026 (initiated Jan 6, 2026) |
| Status | Open, Classified |
| Reason | The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. |
| Root cause | Under Investigation by 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 ret |
| Quantity | 561 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.