Home / Recalls / Integra LifeSciences Corp. / Z-0256-2025

Z-0256-2025 Class II Ongoing

Recalled by Integra LifeSciences Corp. — Princeton, NJ

FDA device recall Z-0256-2025 was initiated by Integra LifeSciences Corp. on September 20, 2024 and is designated Class II. Reason for recall: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in fin… The recall status is ongoing. Affected quantity: 3494 units.

Recall Details

Product Type: Devices
Report Date: November 6, 2024
Initiation Date: September 20, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3494 units

Product Description

SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

Reason for Recall

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Distribution Pattern

Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand Netherlands (the) Belgium France Ireland Switzerland Brunei Darussalam Bahamas (the) South Africa China Ecuador Korea (the Republic of) Czechia Kuwait Luxembourg French Guiana Mayotte Burundi Reunion Martinique Poland Costa Rica Japan Senegal Turkey Serbia Mexico Cambodia Spain Ghana Iceland Jersey Iraq Bahrain Lebanon Dominican Republic (the) Singapore Portugal Greece Austria C¿te d'Ivoire Palestine, State of Georgia Nigeria Slovenia Sweden Colombia United Arab Emirates (the) Saudi Arabia Qatar Hong Kong Oman Albania Panama Holy See (the) Kenya Pakistan Guernsey Morocco Chile Brazil Argentina Puerto Rico Rwanda Jordan Philippines (the) Hungary Romania Bolivia (Plurinational State of) Malaysia El Salvador Peru Lithuania Republic of North Macedonia Taiwan (Province of China) Israel Cyprus Bulgaria

Code Information

UDI-DI: 10381780515135, 20886704036651 Note: the same product code was distributed for a few years under JnJ under a transition agreement with Integra. Therefore, 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.

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