Recall Z-1898-2020
NuVasive Inc · initiated February 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: Part Number: MC2-4570R Product: MAGEC 2 ROD, 4.5mm 70mmOFFSET Lot Numbers: 8061403AAA 8061411AAA 8061419AAA 8061419AAB 8061508AAA 8061808AAA 8061809AAA 8062301AAA 8062602AAA 8062705AAA 8062810AAA 8062810AAB 8063003AAA 8063011AAA 8072409AAA 8072501AAA 8072505AAA 8072627AAA 8072628AAA 8080805AAA 8081102AAA 8092609AAA 8100810AAA 8101905AAA 8102003AAA 8103165AAA 8110306AAA 8111202AAA 8111504AAA 8111508AAA 8122101AAA 8122610AAA 9011102AAA 9011428AAA 9011429AAA 9021601AAA 9021603AAA 9022703AAA 9031511AAA 9031601AAA 9032002AAA 9032901AAA 9032914AAA 9032915AAA 9042508AAA 9042601AAA 9070104AAA 9070112AAA 9071114AAA 9071521AAA 9071610AAA 9071617AAA 9072215AAA 9072701AAA 9072702AAA 9072705AAA 9073001AAA 9073022AAA 9081501AAA 9081502AAA 9082113AAA 9091905AAA 9091906AAA 9112302AAA 9121924AAA 9121938AAA 9121941AAA 9122622AAA Part Number: MC2-4570S Product: MAGEC 2 ROD, 4.5mm 70mmSTANDARD Lot Numbers: 8060727AAA 8061101AAA 8061106AAA 8061203AAA 8061204AAA 8061213AAA 8061214AAA 8061218AAA 8061318AAA 8062307AAA 8062622AAA 8062713AAA 8062902AAA 8063005AAA 8070206AAA 8071001AAA 8071118AAA 8071208AAA 8072508AAA 8072510AAA 8080703AAA 8080902AAA 8081001AAA 8081010AAA 8081011AAA 8081012AAA 8091324AAA…
Reason for recall
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-determined cause: Process control
Action taken
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
Details
- Recall number
- Z-1898-2020
- Initiated
- February 13, 2020
- Terminated
- May 25, 2022
- Product code
- PGN – Growing Rod System- Magnetic Actuation
- 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, Belgium, Bulgaria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, Hungary, India…
- Recalling firm
- NuVasive Inc, San Diego, CA