FDA-Device2014-10-29Class II
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.
Zimmer, Inc.
Hazard
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Sold states
Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan
Affected count
618 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0123-2015Don't want to check this manually?
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