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Exactech, Inc. recalls Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-
Recalled March 27, 2013 · FDA recall Z-0953-2013 · Exactech
Hazard
A dimensional mismatch was identified which can potentially allow for interference between devices. · FDA Class II
Units
123 devices
Sold at
Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
Description
A dimensional mismatch was identified which can potentially allow for interference between devices.
Product
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →