Device product
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-2551-2018
Product summary
- Event
- Event 79855
- Status
- Terminated
- Classification
- Class II
- Quantity
- 124 units
- Official record key
device-enforcement:Z-2551-2018
Official wording
Reason: The main vial label lists the incorrect part number, but the cap label is correct.
Code information: Lot #87837
Distribution pattern: Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
Derived failure modes
-
Labeling or packaging
label lists the incorrect