Device product
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Z-0316-2022
Product summary
- Event
- Event 89007
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0316-2022
Official wording
Reason: The package contents and package labeling do not match.
Code information: Model 220223214E, Lot Code 06113718691661809 (GTIN: 00840420125033)
Distribution pattern: US Nationwide distribution in the states of MI and PA.
Derived failure modes
-
Unknown
The package contents and package labeling do not match.