Reported Dec 28, 2022 · Ongoing
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
NuVasive Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NuVasive Inc · 7475 Lusk Blvd · San Diego, CA · 92121-5707
Is this the product you have?
- X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 887517424211Lot Numbers: EM3755 EM3755 EM3755 EM3761 EM5349 EM5349 EM5349 EM6061 NN1674 NN2646 NN1674 NN2646 NN3352 PD0066 NN3352 PD0515 PD0066 PD0515 7160014 / 887517424211 2 887517426277Lot Numbers: EM3756 EM3756 EM3756 EM3756 EM3762 EM5351 EM6064 EM6062 EM6063 NN1902 NN3350 NN1902 NN3350 PD0392 PD0805 PD0805 PD0392 7180016 / 887517426277 3 887517426284Lot 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 4 887517434210Lot 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 5 887517434227Lot Numbers: EM3765 EM3759 EM6072 EM6072 7220018 / 887517434227 6 Lot Numbers: EM3760 EM3766 EM3760 EM3760 EM6073 - Amount recalled
- 2,031 devices
Where it was sold
Why it was recalled
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new NuVasive Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.