# FDA recall Z-1453-2022

> **NuVasive Inc** · Class II · device recall initiated 2022-06-20.

## 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

## Reason for recall

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

## Key facts

- **Recall number:** Z-1453-2022
- **Recalling firm:** NuVasive Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-20
- **Report date:** 2022-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1453-2022

## Citation

> AI Analytics. FDA recall Z-1453-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1453-2022. Source: US FDA. Licensed CC0.

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