FDA recall Z-3250-2018

Zimmer Biomet, Inc. · Class II · device

Product

Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty

Reason for recall

The implant only has one bolt in the sterile package but it should have had two.

Distribution

Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.

Key facts

Status
Terminated
Initiation date
2018-08-02
Report date
2018-10-03
Termination date
2019-04-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3250-2018