Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.

FDA Recall Z-0738-2023 · Posted 2022-12-20

Recalling FirmNuVasive Inc
Recall StatusOpen, Classified
Product CodeMQP
Date Initiated2022-11-10
Product Quantity2,031 devices

Reason for Recall

Potential that insert will be unable to disengage from the vertebral body replacement device/implant

Firm 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 during patient care of those being treated with Static X-Core devices. This interference presents when attempting to engage or disengage the Static Core implant from the inserter. - The IFU and STG should be consulted on an ongoing basis before and throughout patient treatment. - A NuVasive representative will be contacting their office to help with any questions or concerns. - Acknowledgement of these changes is critical. Review, complete, sign and return the attached Consignee Confirmation Form in accordance with the directions on the form (accompanying this notification). Updated IFU and STG Language: When assembling the construct with static cores, only utilize dismantlable inserters. When utilizing 16mm static cores, refer to the Surgical Technique for instructions on removing the internal gear drive from the appropriate dismantlable inserter. To help achieve proper inserter/implant engagement, the inserter s colored distal tip must face up toward the like-colored spinning sleeve of the implant. To help achieve proper anatomical alignment, the rounded corners of the X-Core shape endcaps must face anterior during implant construction and placement. Care should be taken to confirm that all components are ideally fixated prior to closure.

Root Cause

Device Design

Distribution Pattern

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, Spain, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090176NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEMNuvasive, Inc. · 2009-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑