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NuVasive Inc recalls NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use sp
Recalled May 13, 2020 · FDA recall Z-1898-2020 · NuVasive
Hazard
Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration. · FDA Class II
Units
3502 rods
Sold at
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The Countries of Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Ireland, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Netherlands, Norway, Philippines, Poland, Portugal, Saudi Arabia, Slovenia/Serbia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Description
Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration.
Product
NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be sterilized by the end user).
Manufacturer(s)
NuVasive Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →