NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Summary
The FDA issued a Class III for NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version by NuVasive Inc. Reason: Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, a.
Details
Source
Device Recall
External ID
Z-1052-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product Description
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Lot/Code Info: Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030
Quantity Affected: 7
Reason for Recall
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
Distribution
U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-19
Company
San Diego, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 163 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-1052-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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