Recall Z-0738-2023 ยท MQP Spinal Vertebral Body Replacement Device
NuVasive Inc
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
| Date | Dec 20, 2022 (initiated Nov 10, 2022) |
| Status | Open, Classified |
| Reason | Potential that insert will be unable to disengage from the vertebral body replacement device/implant |
| Root cause | Device Design |
| Action | On 11/10/2022, the firm sent an "URGENT FIELD SAFETY NOTICE" Letter via email to customers informing them that the firm has received product complaints regarding difficulty in disengaging the Inserter from the X-Core, Static Core implant. NuVasive is updating the Instructions For Use (IFU) and Surgical Technique Guide (STG) to clarify the best fit inserter with each core which can help prevent the user experiencing interference when removing the inserter from the Static Core. Recommended User Actions: This FSN details updates to the IFU document that physicians should consult prior to and |
| Quantity | 2,031 devices |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of NC, CA, FL, KY, IL, TX, CO, OH, AK, GA, UT, MA, WA, HI, AL, NY, WI, AR, ID, VA, PA, SC, MD, PA, AZ, RI, IN, ME, NJ, MI, TN, MN, OR, OK, WY, and Puerto Rico. The countries of Australia, Belgium, Brazil, Colombia, Germany, Italy, Spai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090176 | NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM Nuvasive, Inc., Apr 27, 2009 |