FDA recall Z-0083-2019

Orthosensor, Inc. · Class II · device

Product

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.

Reason for recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Distribution

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

Key facts

Status
Terminated
Initiation date
2018-07-12
Report date
2018-10-17
Termination date
2019-06-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dania, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2019