FDA recall Z-1052-2023

Product

NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

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.

Key facts

Status

Ongoing

Initiation date

2022-07-19

Report date

2023-02-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1052-2023