Public recall detail

Surgimend and Primafix Endotoxin Tests

2023-06-08

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Recall Safety notice
Quick summary

Quick summary: Surgimend and Primafix Endotoxin Tests. Date: 2023-06-08.

Recommended action

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

Recall details

Quick summary: Surgimend and Primafix Endotoxin Tests. Date: 2023-06-08.

Official details

Affected product details

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

BrandTei Biosciences Inc.
ProductSurgimend and Primafix Endotoxin Tests
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73764

Affected products

ProductAffected products
LotLot or serial number
ModelModel or catalogue number
Serial numberLot or serial number
DescriptionAffected products
ProductSurgimend
LotMore than 10 numbers, contact manufacturer.
Model606-001-007 606-001-018 606-003-001 606-004-107 606-200-002 606-200-008 606-300-006 606-300-020 606-400-006 607-001-009 606-001-004 606-001-009 606-004-100 606-004-104 606-004-106 606-200-006 606-200-017 606-300-008 606-300-019 606-404-001 606-001-002 606-001-013 606-004-109 606-200-009 606-300-009 606-304-002 606-400-002 607-001-125 606-001-006 606-003-003 606-200-004 606-200-020 606-400-004 606-400-017 607-001-812 606-003-002 606-004-110
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSurgimend
ProductSurgimend
LotMore than 10 numbers, contact manufacturer.
Model606-200-016 606-200-019 606-001-005 606-001-008 606-004-101 606-004-102 606-004-103 606-004-108 606-300-002 606-300-004 606-400-009 606-400-018 606-403-001 607-001-440 606-001-010 606-001-014 606-004-105 606-300-022 607-001-112 607-001-880 606-001-012 606-001-015 606-001-016 606-001-017 606-300-016 606-300-017 606-400-016 607-001-225 607-001-660
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSurgimend
ProductPrimatrix Fenestrated
Lot2003035 1801029 2007013 2010027 2208046 2207029 2010028 2204008 2112022 2107014
Model607-004-440 607-004-660 607-004-880
Serial number2003035 1801029 2007013 2010027 2208046 2207029 2010028 2204008 2112022 2107014
DescriptionPrimatrix Fenestrated
ProductPrimatrix
Lot2104020 1905054 1707052 2005009 2107047
Serial number2104020 1905054 1707052 2005009 2107047
DescriptionPrimatrix
ProductPrimatrix Meshed
LotMore than 10 numbers, contact manufacturer.
Model607-005-440 607-005-330 607-005-880 607-005-550 607-005-220 607-005-125 607-005-660 607-005-812 607-005-225
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPrimatrix Meshed

Issue

Based on an internal investigation, Integra Lifesciences has identified issues with in-process and finished goods endotoxin testing that may result in out of specification endotoxin results. Accordingly, we are recalling those products per the instructions in the attached customer letter. Recall start date: May 29, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesTei Biosciences Inc. 7 Elkins Street, Boston, Massachusetts, United States, 02127
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73764
Background{}
CompaniesTei Biosciences Inc. 7 Elkins Street, Boston, Massachusetts, United States, 02127
AudiencesHealthcare
Source updated2023-06-08

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

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