Recall Z-1898-2020 · PGN Growing Rod System- Magnetic Actuation
NuVasive Inc
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).
| Date | Feb 13, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | The Recalling Firm sent an "URGENT FIELD SAFETY NOTICE" to customers via email and/or FedEx informing them that Post-implantation separation of an actuator end cap component has been observed and that separation of the end cap 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. The firm also informed customers that the long-term ability of a rod with a separated actuator end cap to continue to lengthen/distract is currently unknown. Distribut |
| Quantity | 3502 rods |
| Distribution | 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, Belg |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171791 | MAGEC® System Nuvasive Specialized Orthopedics, Incorporated, Aug 31, 2017 |