FDA recall Z-1256-2024
Paragon 28, Inc. · Class II · device
Product
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Reason for recall
Medical devices distributed, prior to sterilization
Distribution
US:CA OUS: None
Key facts
- Status
- Ongoing
- Initiation date
- 2023-12-21
- Report date
- 2024-03-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Englewood, CO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1256-2024