Recall Z-1322-2024 ยท NDP Accessories, Implant, Dental, Endosseous
Thommen Medical AG
impression coping, repositionable, short, screw-retained, PF 4.0
| Date | Mar 20, 2024 (initiated Jan 24, 2024) |
| Status | Open, Classified |
| Reason | The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant. |
| Root cause | Process change control |
| Action | Urgent Field Safety Notice letters dated February 05, 2024 were sent to customers. Customers were instructed to: Ensure that the contents of this Field Safety Notice are read and understood within your organization. Locate and quarantine affected devices immediately. If you have further distributed the product to other organizations, please inform them at once of this FSCA and provide them with a copy of this letter. Return all affected products of the listed lot number to Thommen Medical AG. The products will be replaced by Thommen MedicalAG. Please acknowledge and confirm receipt of this urg |
| Quantity | 20 units |
| Distribution | US Nationwide distribution in the states of OH and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.