Public recall detail

Magec 1

medium
Recall Safety notice
Quick summary

Quick summary: Magec 1.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Magec 1.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandNuvasive Specialized Orthopedics, Inc.
ProductMagec 1
IssueMedical devices - Revised instructions for use
Recall classType II
IdentificationRA-63923

Affected products

ProductMagec 1
LotMore than 10 numbers, contact manufacturer.
ModelRA002-5555SL70, RA002-5555SL, RA002-4545SL, RA002-4545SL70
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionMagec 1

Issue

Post-implantation fracture of an internal metallic component (i.e., locking pin) had been observed in early version of Magec rods that were manufactured prior to March 26, 2015. In June 2019, Nuvasive Specialized Orthopedics issued a safety alert to inform users that the safety alert incorrectly stated that the device should be removed after an implantation time of no more than six years. Per the IFU, the device should be removed after implantation time of no more than two years. Recall start date: Jan 31, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Orthopaedics
CompaniesNuvasive Specialized Orthopedics, Inc. 101 Enterprise, Aliso Viejo, California United States, 92656
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63923
Background{}
CompaniesNuvasive Specialized Orthopedics, Inc. 101 Enterprise, Aliso Viejo, California United States, 92656
AudiencesGeneral public Health professionals Hospitals
Source updated2022-02-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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