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).
Recall
- Recall Number
- Z-1898-2020
- Event Number
- 85495
- Firm
- NuVasive Inc
- FEI Number
- 3002980729
- Product Code
- PGN
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- February 13, 2020
- Terminated
- May 25, 2022
- Address
- 7475 Lusk Blvd, San Diego, CA, 92121-5707
Description
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).
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.
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. Distributors were contacted via email on 2/17/2020 Surgeons US were contacted via email and/or FedEx between 2/14/2020 to 2/18/2020. Surgeons OUS were contacted via email between 2/17/2020 to 2/21/2020. The Recalling Firm is recommending that surgeons perform routine clinical follow-up and discuss potential clinical implications and risks with patients who received affected products. The Recalling Firm is not recommending prophylactic revision based solely on the separation of an end cap. However, if an end cap separation is detected, removal of the device may be indicated. The decision to remove the device should be made by the physician in consultation with the patient and/or family. The Recalling Firm's Recommended User Action: -Immediately examine inventory to determine if they have product subject to this action on hand and quarantine the product. The Recalling Firm's representative will visit offices or contact customers directly to provide instructions for the return of the affected products. -Review, complete, sign and return the attached Consignee Confirmation Form accompanying the notification in accordance with the directions on the form. -Do not implant rods until further notice. -Review the details below and understand how to identify a separated end cap on postoperative XRay imaging: -Users should follow the appropriate postoperative procedure to assess the
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.
3502 rods