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X-CORE recallZ-0738-2023 · NuVasive Inc · initiated Nov 10, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from NuVasive Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0738-2023
Status
Open, Classified
Initiated by the company
Nov 10, 2022
Posted by the FDA
Dec 20, 2022
Recalling firm
NuVasive Inc
Quantity
2,031 devices
Product code
MQP
FDA submissions
K090176
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.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

16 devices cleared under K090176 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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