Device product
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Z-1189-2018
Product summary
- Event
- Event 78667
- Status
- Terminated
- Classification
- Class II
- Quantity
- 995 distribution events total
- Official record key
device-enforcement:Z-1189-2018
Official wording
Reason: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Code information: Lot No. 63621027, UDI #(01)00889024019928 (17)220331 (10)63619437.
Distribution pattern: Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
Derived failure modes
-
Labeling or packaging
mislabeled