Device product
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Z-0973-2013
Product summary
- Event
- Event 64633
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-0973-2013
Official wording
Reason: Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Code information: Lot Number: 12857
Distribution pattern: Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
Derived failure modes
-
Labeling or packaging
Mislabeled