X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Summary
The FDA issued a Class II for X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System use by NuVasive Inc. Reason: Potential that insert will be unable to disengage from the vertebral body replacement device/implant.
Details
Source
Device Recall
External ID
Z-0738-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Lot/Code Info: 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
Quantity Affected: 2,031 devices
Reason for Recall
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-10
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NuVasive Inc has 6 FDA actions in our database, including 3 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NuVasive Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NuVasive Inc have FDA actions?
NuVasive Inc has 6 FDA actions in our database, including 3 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0738-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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