# FDA recall Z-0319-2022

> **NuVasive Specialized Orthopedics, Inc.** · Class II · device recall initiated 2021-10-29.

## Product

NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System:  Model Number/Item Number/Product Description:  CPA1-000	PA0382-001	End Cap   CPA2-000	PA1051-000	PACKAGED END CAP, 8.5/ 10.7MM, +0MM  CPA2-005	PA1051-005	PACKAGED END CAP, 8.5/ 10.7MM, +5MM  CPA2-010	PA1051-010	PACKAGED END CAP, 8.5/ 10.7MM, +10MM  CPA2-015	PA1051-015	PACKAGED END CAP, 8.5/ 10.7MM, +15MM  CPA2-020	PA1051-020	PACKAGED END CAP, 8.5/ 10.7MM, +20MM  CPA3-000	PA1052-000	PACKAGED END CAP, 12.5MM , +0MM  CPA3-005	PA1052-005	PACKAGED END CAP, 12.5MM , +5MM  CPA3-010	PA1052-010	PACKAGED END CAP, 12.5MM , +10MM  CPA3-015	PA1052-015	PACKAGED END CAP, 12.5MM , +15MM  CPA3-020	PA1052-020	PACKAGED END CAP, 12.5MM , +20MM  HEC1-000	PA0709-000	END CAP, 0MM HUMERAL NAIL  HEC2-000	PA0709-002	END CAP, 2MM HUMERAL NAIL  HEC3-000	PA0709-005	END CAP, 5MM HUMERAL NAIL  HEC4-000	PA0709-010	END CAP, 10MM HUMERAL NAIL  HEC5-000	PA0709-015	END CAP, 15MM HUMERAL NAIL  LSB3-020	PP1699-020	Locking Screw, 3.5mm x 2 0mm  LSB

## Reason for recall

The Instructions for Use have been updated to include:   (1) Clarification that the device is intended for use only in patients 18 years and older,   (2) That patients should weigh 50 lbs. or more while undergoing treatment, and    (3) That no more than two devices should be implanted at a time.

## Distribution

U.S.: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI,  and WV.    O.U.S.: Argentina, Australia, Austria, Belgium, Canada, Colombia, Chile, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jordan, Luxemburg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, UAE, United Kingdom.

## Key facts

- **Recall number:** Z-0319-2022
- **Recalling firm:** NuVasive Specialized Orthopedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-29
- **Report date:** 2021-12-08

- **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-0319-2022

## Citation

> AI Analytics. FDA recall Z-0319-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0319-2022. Source: US FDA. Licensed CC0.

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