Class 2 Device Recall XCORE 2 Ti Core, Static

• Date Initiated by Firm: November 10, 2022
• Date Posted: December 20, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0738-2023
• Recall Event ID: 91196
• 510(K)Number: K090176
• Product Classification: Spinal vertebral body replacement device - Product Code MQP
• Product: X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
• Code Information: Part Numbers / UDI-DI Code: 7160012 /887517424204, Lot Numbers: EM3755 EM3755 EM3755 EM3761 EM5349 EM5349 EM5349 EM6061 NN1674 NN2646 NN1674 NN2646 NN3352 PD0066 NN3352 PD0515 PD0066 PD0515 7160014 / 887517424211, Lot Numbers: EM3756 EM3756 EM3756 EM3756 EM3762 EM5351 EM6064 EM6062 EM6063 NN1902 NN3350 NN1902 NN3350 PD0392 PD0805 PD0805 PD0392 7180016 / 887517426277, Lot Numbers: EM3763 EM3757 EM3757 EM3757 EM5353 EM5352 EM6068 EM6067 EM6066 EM6065 DR6677 DR6677 DR6901 DR6958 DR7357 DR7357 DR8110 DR8465 DR8897 DR9443 DR7357 DR9592 DR9592 DR9443 DR9592 DR9592 NN1445 NN1445 NN1446 NN1451 NN1445 NN1473 NN1473 NN3294 NN3294 PD0146 PD0146 PD0706 7180018 / 887517426284, Lot Numbers: EM3758 EM3764 EM5354 EM5354 EM6070 EM6069 DR6624 DR6658 DR6957 DR6658 DR7376 DR8930 NN0628 NN0817 NN1360 DR7376 DR7376 NN1891 NN1891 NN1891 NN2971 NN2971 NN3368 NN3368 PD0794 7220016 / 887517434210, Lot Numbers: EM3765 EM3759 EM6072 EM6072 7220018 / 887517434227 Lot Numbers: EM3760 EM3766 EM3760 EM3760 EM6073
• Recalling Firm/ Manufacturer: NuVasive Inc; 7475 Lusk Blvd; San Diego CA 92121-5707
• For Additional Information Contact: Patrick Yrigoyen; 858-336-3421
• Manufacturer Reason for Recall: Potential that insert will be unable to disengage from the vertebral body replacement device/implant
• FDA Determined 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 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.
• Quantity in Commerce: 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, Spain, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MQP