FDA recall Z-1255-2024

Paragon 28, Inc. · Class II · device

Product

Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L

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-1255-2024