NUVASIVE MAGEC 2 Rod X recalled over sterility concerns

Recall date

February 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 spi…

Recall number

Z-1898-2020

FDA classification

Class II

Brand / firm

NuVasive Inc

Sold / distributed

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, Bel…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).