The Recall Desk

Manufacturer

NuVasive Inc

36 recalls in our database name NuVasive Inc as the manufacturing or recalling firm.

What the numbers show

Total
36
Critical
0
Severe
24
Most recent
2023-02-15

Of the 36 recalls from NuVasive Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 24 (67%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 36

  • ModerateFDA (Devices)·Z-1052-2023·2023-02-15

    NuVasive Pulse III Multimodality System remote monitoring connection failure

    An incorrect security key prevents the NuVasive Pulse III system from connecting to remote monitoring during spinal, thoracic, and extremity surgeries. Affected facilities should contact NuVasive for corrective action.

    Product
    NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2023·2022-12-28

    Spinal implant insert may fail to disengage from vertebral body device

    NuVasive's X-CORE 2 spinal implants may not disengage properly from the vertebral replacement device, potentially requiring revision surgery. About 2,031 devices worldwide are affected.

    Product
    X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2022·2022-08-03

    NuVasive Simplify Disc UDI Barcode Contains Incorrect Size Information

    NuVasive Simplify Disc cervical implants have UDI barcodes with incorrect Global Trade Item Numbers that may cause selection of the wrong device size during implant surgery.

    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
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2684-2020·2020-07-29

    Nuvasive NVM5 EMG Module Recalled for Incorrect Component

    NuVasive Inc is recalling 23 NVM5 EMG Modules because they contain an incorrect SSEP harness instead of the correct NVM5 Harness, potentially delaying spinal surgery monitoring.

    Product
    Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1898-2020·2020-05-13

    NuVasive MAGEC 2 Spinal Rods Recalled for Actuator Separation

    NuVasive Inc. is recalling MAGEC 2 spinal rods because actuator end caps may separate, exposing internal components and releasing titanium wear debris.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0348-2013·2012-11-28

    NuVasive Recalls 240 Screw Tulip Implants Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.25mm Screw Tulip implants because the tulip portion can disengage from the shank after implantation.

    Product
    Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0359-2013·2012-11-28

    NuVasive 6.5mm Cannulated Screw Shank Recall for Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0360-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 55mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0375-2013·2012-11-28

    NuVasive Recalls 6.5mm Noncannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0362-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0354-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 55mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0349-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 30mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0361-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 30mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0358-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 45mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0355-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 30mm Cannulated Screw Shanks because the tulip portion may disengage from the shank after implantation.

    Product
    6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0378-2013·2012-11-28

    NuVasive Recalls 7.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0351-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 40mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0363-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 40mm Cannulated Screw Shanks because the tulip portion may disengage from the shank after implantation.

    Product
    7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0369-2013·2012-11-28

    NuVasive Recalls 4.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 4.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0353-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0376-2013·2012-11-28

    NuVasive Recalls 7.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0373-2013·2012-11-28

    NuVasive Recalls 6.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0371-2013·2012-11-28

    NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0364-2013·2012-11-28

    NuVasive Recalls 7.5mm Cannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 45mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0367-2013·2012-11-28

    NuVasive Recalls 240 Screw Tulip Medical Devices for Disengagement Risk

    NuVasive Inc is recalling 240 units of Screw Tulip, 5.5mm Rod devices because the tulip portion can disengage from the shank after implantation.

    Product
    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

NuVasive

American medical device company

Country
United States
Founded
1997

Official website

Source: Wikidata (Q7067716), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.