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Orthohelix Surgical Designs Inc recalls MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside.
Recalled October 15, 2014 · FDA recall Z-0062-2015 · Orthohelix Surgical Designs
Hazard
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer · FDA Class II
Units
38
Sold at
USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.
Description
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Product
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.
Manufacturer(s)
Orthohelix Surgical Designs Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →