Skip to content
Recall Observatory FDA recall evidence

Device product

SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. 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.

Z-0239-2025

September 20, 2024

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 95432
Status
Ongoing
Classification
Class II
Quantity
168803
Official record key
device-enforcement:Z-0239-2025

Official wording

Reason: 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

Code information: UDI#: 10381780514961, 20886704036484 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.

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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification