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Zimmer Biomet, Inc. recalls Persona Partial Knee System, Size 8, Finishing Guide
Recalled January 24, 2018 · FDA recall Z-0349-2018 · Zimmer Biomet
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. · FDA Class II
Units
158 devices
Sold at
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.
Description
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.
Product
Persona Partial Knee System, Size 8, Finishing Guide
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →