FDA-Device2013-03-27Class II
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Exactech, Inc.
Hazard
A dimensional mismatch was identified which can potentially allow for interference between devices.
Sold states
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.
Affected count
123 devices
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0953-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief