FDA recall Z-1468-2022
Paragon 28, Inc. · Class II · device
Product
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Reason for recall
Due to Titanium plasma coating not present implant.
Distribution
U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
Key facts
- Status
- Ongoing
- Initiation date
- 2022-05-26
- Report date
- 2022-08-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Englewood, CO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2022