FDA recall Z-1011-2018

Product

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

Reason for recall

The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

Distribution

US Distribution to states of: FL, WI, MD, MO, and MI.

Key facts

Status

Terminated

Initiation date

2017-10-03

Report date

2018-03-21

Termination date

2018-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1011-2018