FDA-Device2014-10-15Class II
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Orthohelix Surgical Designs Inc
Hazard
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Sold states
USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.
Affected count
38
Manufactured in
1065 Medina Rd Ste 500, Medina, OH, United States
Products
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0062-2015Don't want to check this manually?
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