CLASS II ONGOING Device recall · Reported 2 Feb 2022 · FDA Enforcement Report

Magec 1 System recalled by NuVasive Specialized

NuVasive Specialized Orthopedics is recalling Magec 1 System. The recall was initiated on 25 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.

Quantity recalled3,056 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0528-2022
FDA event ID: 89177
Recalling firm: NuVasive Specialized Orthopedics, Aliso Viejo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Jun 2019
FDA classified: 26 Jan 2022
Reported: 2 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Jun 2019	Recall initiated by company
26 Jan 2022	Classified by FDA	+946 days
2 Feb 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

Product as listed by the FDA

MAGEC 1 System

Where it was distributed

Worldwide

Questions about this recall

Is Magec 1 System recalled?

Yes. NuVasive Specialized Orthopedics recalled Magec 1 System on 25 Jun 2019. The recall is Class II and its status is Ongoing. Recall number Z-0528-2022.

Why was it recalled?

Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

Which lots are affected?

All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from NuVasive Specialized Orthopedics

All 9

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27 Nov 2024Device	CLASS II	Precice Max recalled by NuVasive Specialized	NuVasive Specialized Orthopedics	Other	FL, NV
21 Dec 2022Device	CLASS II	Nuvasive Magec Magec 2 Rod recalled by NuVasive Specialized	NuVasive Specialized Orthopedics	Sterility	Nationwide
14 Apr 2021Device	CLASS II	Nuvasive Precice Intramedullary Limb Lengthening (Imll) recalled	Nuvasive Specialized Orthopedics	Packaging Defects	Nationwide
14 Apr 2021Device	CLASS II	Nuvasive Freedom: End Cap for Precice Intramedullary Limb recalled	Nuvasive Specialized Orthopedics	Packaging Defects	Nationwide
14 Apr 2021Device	CLASS II	Nuvasive Precice Unyte System (Humerus and Tibia) recalled	Nuvasive Specialized Orthopedics	Other	Nationwide

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