NuVasive Inc: 36 FDA recall reports
Every medical device recall the FDA has published for NuVasive Inc. The fault, and how the agency graded it.
36Reports
0Class I
3Ongoing
2023-02-15Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Z-1052-2023 · Class III · reported 2023-02-15 · Ongoing
- 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.
- Product
- NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
- Where it went
- U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
- How much
- 7
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Z-0738-2023 · Class II · reported 2022-12-28 · Ongoing
- Why it was recalled
- Potential that insert will be unable to disengage from the vertebral body replacement device/implant
- Product
- X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
- Where it went
- 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, Spain, and United Kingdom.
- How much
- 2,031 devices
Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2,
Z-1453-2022 · Class II · reported 2022-08-03 · Ongoing
- Why it was recalled
- 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.
- Product
- 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/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplify Disc Size 3, Ht 5, 5/LG-5L; Simplify Disc Size 3, Ht 6/LG-6; Simplify Disc Size 3, Ht 6, 5/LG-6L
- Where it went
- US: CA, WA, TX, IN, MO, MI, FL, VA, OR. OUS: DE, NZ, SG, UK
- How much
- 1,963
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is i
Z-2684-2020 · Class II · reported 2020-07-29 · Terminated
- 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.
- Product
- Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
- Where it went
- US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None
- How much
- 23
NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile sin
Z-1898-2020 · Class II · reported 2020-05-13 · Terminated
- Why it was recalled
- 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.
- Product
- 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 Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be sterilized by the end user).
- Where it went
- 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, Belgium, Bulgaria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Ireland, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Netherlands, Norway, Philippines, Poland, Portugal, Saudi Arabia, Slovenia/Serbia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
- How much
- 3502 rods
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0357-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0361-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0376-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0352-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0359-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0360-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0348-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0364-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0373-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0378-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0358-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0355-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0356-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0363-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0351-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0349-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0369-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0353-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0375-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0350-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0377-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0374-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0362-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0372-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0366-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Product
- 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Where it went
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- How much
- 240 units total
Showing the 30 most recent of 36. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls