FDA recall Z-0775-2018

Product

979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.

Reason for recall

Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.

Distribution

Distribution includes US Nationwide.

Key facts

Status

Terminated

Initiation date

2017-09-13

Report date

2018-03-07

Termination date

2020-04-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0775-2018