Recall Z-1302-2013— Integra LifeSciences Corporation

Name: FDA recall Z-1302-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-28

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corporation, initiated 2013-03-28, terminated 2015-06-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Absorbable Collagen Sponge Provided As Intermediate to Another Company. Reason: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products..

Recalling firm: Integra LifeSciences Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Terminated: 2015-06-03
Firm location: Plainsboro, NJ, United States

Product description

Absorbable Collagen Sponge Provided As Intermediate to Another Company

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Data sourced from openFDA. This site is unofficial and independent of the FDA.