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Recall Observatory FDA recall evidence

Device product

NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Z-1287-2013

March 28, 2013

Class II

Product summary

Firm
Integra LifeSciences Corporation
Event
Event 64778
Status
Terminated
Classification
Class II
Quantity
1,661 boxes
Official record key
device-enforcement:Z-1287-2013

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: 1105457 1112377, 1112378 1112103 1112106, 1112003, 1112296, 1110715 1112052, 1112004, 1112030 1111972 1112376

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

Field note

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