Recall Z-1561-2025 ยท NDP Accessories, Implant, Dental, Endosseous
Straumann USA LLC
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
| Date | Apr 14, 2025 (initiated Mar 8, 2025) |
| Status | Open, Classified |
| Reason | The devices are missing the laser marked depth markings. |
| Root cause | Process control |
| Action | On March 8, 2024 URGENT FIELD SAFETY ACTION letters were sent to customers. Action to be taken: 1. If Article 037.3002 from Lots LGMZ8 and GLKJ9 is still in your inventory, then stop use/distribution of the product immediately and quarantine/segregate physically. 2. If Article 037.3002 from Lots LGMZ8 and GLKJ9 is still in your inventory, return it for a replacement as indicated on the Customer Confirmation Form 3. 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 Ando |
| Quantity | 45 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the countries of Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Switzerland, Ukraine, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.