NuVasive Inc
Complete recall history across all FDA and CPSC categories — 36 total recalls
NuVasive Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (36)
FDA medical device enforcement actions by NuVasive Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 10, 2022 | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System ... | Potential that insert will be unable to disengage from the vertebral body rep... | Class II |
| Jul 19, 2022 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... | Due to an incorrect security key, customers were unable to connect to remote ... | Class III |
| Jun 20, 2022 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, H... | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the ... | Class II |
| Jun 10, 2020 | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 008... | The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitori... | Class II |
| Feb 13, 2020 | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product ... | Post-implantation separation of an actuator end cap component that may expose... | Class II |
| Jan 5, 2009 | Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
| Jan 5, 2009 | 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after im... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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