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

Recall date

July 19, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1052-2023

FDA classification

Class III

Brand / firm

NuVasive Inc

Sold / distributed

U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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