FDA recall Z-0423-2018

Product

Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM

Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Distribution

US nationwide distribution. Also Portugal and the Netherlands.

Key facts

Status

Terminated

Initiation date

2017-08-07

Report date

2018-02-07

Termination date

2019-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0423-2018