Recall Z-1286-2013— Integra LifeSciences Corporation

Name: FDA recall Z-1286-2013
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. It names 2 FDA 510(k) clearances: K072207, K041620. Product: NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.. 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

510(k) clearances named in this recall

2 on FDA's record

K072207 — DURAGEN XS DURAL REGENERATION MATRIXIntegra Lifesciences Corp.·cleared 2007-08-23
K041620 — NEURA WRAP NERVE PROTECTORIntegra Lifesciences Corp.·cleared 2004-07-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

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.