FDA-Device2018-10-17Class II
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
Orthosensor, Inc.
Hazard
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Sold states
Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
Affected count
36 devices
Manufactured in
1855 Griffin Rd Ste A310, Dania, FL, United States
Products
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2019Don't want to check this manually?
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