Public recall detail

Durepair Dura Subsitute

2023-06-30

medium
Recall Safety notice
Quick summary

Quick summary: Durepair Dura Subsitute. Date: 2023-06-30.

Recommended action

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

Recall details

Quick summary: Durepair Dura Subsitute. Date: 2023-06-30.

Official details

Affected product details

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

BrandMEDTRONIC INC.
ProductDurepair Dura Subsitute
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-73891

Affected products

ProductDurepair Dura Subsitute
LotMore than 10 numbers, contact manufacturer.
Model61110 61105 61111 61100 61106
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDurepair Dura Subsitute

Issue

Medtronic was informed by the contract manufacturer that based on internal investigation they have identified issues with in-process and finished goods endotoxin testing. these issues may have resulted in the release of product with out-of-specification endotoxin levels. Recall start date: June 13, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesMedtronic Inc. 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73891
Background{}
CompaniesMedtronic Inc. 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
AudiencesHealthcare
Source updated2023-06-30

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

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