FDA recall Z-0776-2020
Nextremity Solutions · Class II · device
Product
Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
Reason for recall
Components 2mm shorter than indicated on the package label
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2019-11-11
- Report date
- 2020-01-15
- Termination date
- 2020-09-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Warsaw, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0776-2020