Integra LifeSciences Corporation recalls NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in w

Recalled May 22, 2013 · FDA recall Z-1286-2013 · Integra LifeSciences

Hazard

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. · FDA Class II

Units

954 boxes

Sold at

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Description

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.

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.

Manufacturer(s)

Integra LifeSciences Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →