# FDA recall Z-1349-2021

> **Nuvasive Specialized Orthopedics Inc** · Class II · device recall initiated 2021-02-12.

## Product

NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System    End Cap for PRECICE Intramedullary Limb Lengthening System Implant;  Packaged End Cap 8.5/10.7mm,¿ +0mm;  Packaged End Cap 8.5/10.7mm,¿ +5mm;  Packaged End Cap 8.5/10.7mm,¿ +10mm;  Packaged End Cap 8.5/10.7mm,¿ +15mm;  Packaged End Cap 8.5/10.7mm,¿ +20mm;  Packaged End Cap 12.5mm,¿ +0mm;  Packaged End Cap 12.5mm,¿ +5mm;  Packaged End Cap 12.5mm,¿ +10mm;  Packaged End Cap 12.5mm,¿ +15mm;  Packaged End Cap 12.5mm,¿ +20mm;  3.5 mm Locking Screw, 20 mm Length;  3.5 mm Locking Screw 25 mm Length;  3.5 mm Locking Screw 30 mm Length;  3.5 mm Locking Screw 35 mm Length;  3.5 mm Locking Screw 40 mm Length;  3.5 mm Locking Screw 45 mm Length;  3.5 mm Locking Screw 50 mm Length;  3.5 mm Locking Screw 55 mm Length;  3.5 mm Locking Screw 60 mm Length;  Locking Screw, 3.5x65mm;  Locking Screw, 3.5x70mm;  Locking Screw, 3.5x75mm;  4.0 mm Locking Screw 20 mm Length;  4.0 mm Locking Screw 25 mm Length;  4.0 mm Locking Screw 3

## Reason for recall

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

## Distribution

Worldwide distribution, including U.S. Nationwide.

## Key facts

- **Recall number:** Z-1349-2021
- **Recalling firm:** Nuvasive Specialized Orthopedics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-12
- **Report date:** 2021-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aliso Viejo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1349-2021

## Citation

> AI Analytics. FDA recall Z-1349-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1349-2021. Source: US FDA. Licensed CC0.

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