San Diego, CA, United States
NuVasive Inc recalls
5 recalls recorded since 2018, most recently on 10 November 2022. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)3
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 November 2022
- Reason
- Potential that insert will be unable to disengage from the vertebral body replacement device/implant
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of NC, CA, FL, KY, IL, TX, CO, OH, AK, GA, UT, MA, WA, HI, AL, NY, WI, AR, ID, VA, PA, SC, MD, PA, AZ, RI, IN, ME, NJ, MI, TN, MN, OR, OK, WY, and Puerto Rico. The countries of Australia, Belgium, Brazil, Colombia, Germany, Italy, Spai
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0738-2023
- X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Ongoing Class III Medical devices
- Recall started
- 19 July 2022
- 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.
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1052-2023
- NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Ongoing Class II Medical devices
- Recall started
- 20 June 2022
- Reason
- Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
- Distribution
- US: CA, WA, TX, IN, MO, MI, FL, VA, OR. OUS: DE, NZ, SG, UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1453-2022
- Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6
Terminated Class II Medical devices
- Recall started
- 10 June 2020
- Terminated
- 22 March 2021
- Reason
- 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.
- Distribution
- US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2684-2020
- Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
Terminated Class II Medical devices
- Recall started
- 13 February 2020
- Terminated
- 25 May 2022
- Reason
- Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The Countries of Argentina, Austria, Belg
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1898-2020
- NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and A
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.