FDA recall Z-0723-2021

Product

Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422

Reason for recall

Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

Distribution

Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.

Key facts

Status

Terminated

Initiation date

2020-12-01

Report date

2020-12-30

Termination date

2022-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0723-2021