Nuvasive NVM5 EMG Module recalled over sterility concerns

Recall date

June 10, 2020

Source

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

Official notice title

NuVasive Inc recalls Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended fo…

Recall number

Z-2684-2020

FDA classification

Class II

Brand / firm

NuVasive Inc

Sold / distributed

US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None

Why it was recalled

The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5 EM. This issue can result in delay in therapy or lack of EMG neuromonitoring during surgery if the surgeon elects to proceed without the NVM5.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.