Drugs & medicalClass II

NuVasive Specialized Orthopedics, Inc. recalls NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of…

During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the…

Read the official notice →
Date
2022-12-21
Country
United States
Brand
NuVasive Specialized Orthopedics
Product
NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model…
Classification
Class II
Units
Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More NuVasive Specialized Orthopedics recalls

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    FDA · DeviceNuVasive Specialized Orthopedics, Inc.U.S distribution to states of: FL and NV.Official notice →
  3. 2022-02-02
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    NuVasive Specialized Orthopedics, Inc. recalls MAGEC 1 System

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    FDA · DeviceNuVasive Specialized Orthopedics, Inc.WorldwideOfficial notice →
  5. 2021-12-08
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    NuVasive Specialized Orthopedics, Inc. recalls NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description:…

    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…

    FDA · DeviceNuVasive Specialized Orthopedics, Inc.U.S.: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice →
All 4 NuVasive Specialized Orthopedics recalls →

Other drugs & medical recalls in the United States

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    knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

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