FDA Device recall Z-0319-2022

NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-0…

FDA Device
Class II
ongoing
Published 2021-12-08

On 2021-12-08 the FDA classified a Class II recall of NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-0… by Nuvasive Specialized Orthopedics, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0319-2022
Classification	Class II
Status	ongoing
Initiated	2021-10-29
Published	2021-12-08
Last updated	2026-09-13 11:56 UTC
Company	Nuvasive Specialized Orthopedics
Distribution	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, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV

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 LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm LSC5-045 P

Reason

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.

Identifiers

code_info	All Lots manufactured between April 2015 to February 2021 UDI/Model No./Item No./Product Description: 812258020002 CPA… All Lots manufactured between April 2015 to February 2021 UDI/Model No./Item No./Product Description: 812258020002 CPA1-000 PA0382-001 End Cap 887517001139 CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM 887517001146 CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM 887517001153 CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM 887517001160 CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM 887517001177 CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM 887517001184 CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM 887517001191 CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM 887517001207 CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM 887517001214 CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM 887517001221 CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM 812258028121 HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL 812258028138 HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL 812258028145 HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL 81

code_info

All Lots manufactured between April 2015 to February 2021 UDI/Model No./Item No./Product Description: 812258020002 CPA…

All Lots manufactured between April 2015 to February 2021 UDI/Model No./Item No./Product Description: 812258020002 CPA1-000 PA0382-001 End Cap 887517001139 CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM 887517001146 CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM 887517001153 CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM 887517001160 CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM 887517001177 CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM 887517001184 CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM 887517001191 CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM 887517001207 CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM 887517001214 CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM 887517001221 CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM 812258028121 HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL 812258028138 HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL 812258028145 HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL 81

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0319-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.