FDA recall Z-0827-2020

Medicrea International · Class II · device

Product

Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130

Reason for recall

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2019-09-16
Report date
2020-01-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rillieux La Pape, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0827-2020