FDA-Device2018-01-24Class II
Persona Partial Knee System, Size 8, Finishing Guide
Zimmer Biomet, Inc.
Hazard
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
Sold states
Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.
Affected count
158 devices
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Persona Partial Knee System, Size 8, Finishing Guide
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0349-2018Don't want to check this manually?
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