Device product
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Z-0089-2019
Product summary
- Event
- Event 80297
- Status
- Terminated
- Classification
- Class II
- Quantity
- 217 units
- Official record key
device-enforcement:Z-0089-2019
Official wording
Reason: Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Code information: Part number 8735-05, Lot number 90212
Distribution pattern: Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
Derived failure modes
-
Labeling or packaging
mislabeled