Device product
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Z-2335-2021
Product summary
- Event
- Event 88395
- Status
- Terminated
- Classification
- Class II
- Quantity
- 499 units
- Official record key
device-enforcement:Z-2335-2021
Official wording
Reason: The kit contains the wrong vial tray in the package.
Code information: Model Number K30003010, Lot 1706343
Distribution pattern: US Nationwide distribution in the states of AK, CA, CO, FL, GA, IA, ID, IL, IN, MA, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, WA, and WI.
Derived failure modes
-
Unknown
The kit contains the wrong vial tray in the package.