Device product
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Z-0406-2018
Product summary
- Event
- Event 78429
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-0406-2018
Official wording
Reason: The expiration date provided on the label is incorrect.
Code information: Lot Numbers: 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R.
Distribution pattern: Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.
Derived failure modes
-
Labeling or packaging
label is incorrect