FDA recall Z-0673-2018

Product

Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty

Reason for recall

Knee implant components (tibial bearings) are labeled with the incorrect size.

Distribution

Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands

Key facts

Status

Terminated

Initiation date

2017-09-29

Report date

2018-02-28

Termination date

2019-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0673-2018