Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1286-2013

March 28, 2013

Class II

Product summary

Firm
Integra LifeSciences Corporation
Event
Event 64778
Status
Terminated
Classification
Class II
Quantity
954 boxes
Official record key
device-enforcement:Z-1286-2013

Official wording

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.

Code information: 1112107 1111938, 1112280, 1112038, 1111971 1112279, 1112104, 1112105 1112297,

Distribution pattern: 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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    process deviation