Recall Z-1052-2023— NuVasive Inc
Class III · Ongoing
Class III FDA medical device recall by NuVasive Inc, initiated 2022-07-19. It names one FDA 510(k) clearance: K210574. Product: NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US. Reason: 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..
- Recalling firm
- NuVasive Inc
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2022-07-19
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.