FDA recall Z-0938-2019

Product

Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766

Reason for recall

Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

Distribution

MN, VA Foreign: Korea, New Zealand and Japan

Key facts

Status

Terminated

Initiation date

2018-12-21

Report date

2019-03-06

Termination date

2020-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2019