FDA recall Z-0316-2022
Wright Medical Technology Inc · Class II · device
Product
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Reason for recall
The package contents and package labeling do not match.
Distribution
US Nationwide distribution in the states of MI and PA.
Key facts
- Status
- Terminated
- Initiation date
- 2021-11-04
- Report date
- 2021-12-08
- Termination date
- 2023-01-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Arlington, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0316-2022