Device product
Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.
Z-0638-2021
Product summary
- Event
- Event 86755
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54 boxes
- Official record key
device-enforcement:Z-0638-2021
Official wording
Reason: The product is mislabeled.
Code information: Lot SK190610, Expiry June 2022
Distribution pattern: Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
Derived failure modes
-
Labeling or packaging
mislabeled