Surgimend and Primafix Endotoxin Tests

Brand(s)

Tei Biosciences Inc.

Last updated

2023-06-08

Summary

Product

Surgimend and Primafix Endotoxin Tests

Issue

Medical devices - Performance issue

What to do

Contact the manufacturer if you require additional information.

Audience

Healthcare

Affected products

Affected products	Lot or serial number	Model or catalogue number
Surgimend	More than 10 numbers, contact manufacturer.	606-001-007 606-001-018 606-003-001 606-004-107 606-200-002 606-200-008 606-300-006 606-300-020 606-400-006 607-001-009 606-001-004 606-001-009 606-004-100 606-004-104 606-004-106 606-200-006 606-200-017 606-300-008 606-300-019 606-404-001 606-001-002 606-001-013 606-004-109 606-200-009 606-300-009 606-304-002 606-400-002 607-001-125 606-001-006 606-003-003 606-200-004 606-200-020 606-400-004 606-400-017 607-001-812 606-003-002 606-004-110
Surgimend	More than 10 numbers, contact manufacturer.	606-200-016 606-200-019 606-001-005 606-001-008 606-004-101 606-004-102 606-004-103 606-004-108 606-300-002 606-300-004 606-400-009 606-400-018 606-403-001 607-001-440 606-001-010 606-001-014 606-004-105 606-300-022 607-001-112 607-001-880 606-001-012 606-001-015 606-001-016 606-001-017 606-300-016 606-300-017 606-400-016 607-001-225 607-001-660
Primatrix Fenestrated	2003035 1801029 2007013 2010027 2208046 2207029 2010028 2204008 2112022 2107014	607-004-440 607-004-660 607-004-880
Primatrix	2104020 1905054 1707052 2005009 2107047
Primatrix Meshed	More than 10 numbers, contact manufacturer.	607-005-440 607-005-330 607-005-880 607-005-550 607-005-220 607-005-125 607-005-660 607-005-812 607-005-225

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

Additional information

Details

Original published date: 2023-06-08

Alert / recall type

Health product recall

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Surgimend and Primafix Endotoxin Tests

Summary

Affected products

Issue

Additional information

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