NuVasive Inc

FDA recalling firm · 6 enforcement events · 36 product records · 2009–2022 · CA

NuVasive Inc has 6 FDA enforcement events on this register (36 product records) between 2009 and 2022: 6 device; the busiest year was 2022 with 3.

0% of its events are Class I; the most common class is Class II (5). 3 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
10 Nov 2022	X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.	Device	Class II	1	Ongoing
19 Jul 2022	NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US	Device	Class III	1	Ongoing
20 Jun 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/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,…	Device	Class II	1	Ongoing
10 Jun 2020	Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.	Device	Class II	1	Terminated
13 Feb 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 Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be…	Device	Class II	1	Terminated
5 Jan 2009	Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI	Device	Class II	31	Terminated

By type and class

Device6

Class II5

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for NuVasive Inc by year initiated.

Questions and answers

How many FDA recalls has NuVasive Inc had?

6 enforcement events (36 product records) on this register, 2009–2022: 6 device.

Are any NuVasive Inc recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are NuVasive Inc recalls?

5 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.