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Recall Observatory FDA recall evidence

Device product

NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Z-1470-2020

February 07, 2020

Class III

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 84960
Status
Terminated
Classification
Class III
Quantity
55
Official record key
device-enforcement:Z-1470-2020

Official wording

Reason: Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.

Code information: Lot # 3388360

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, IN, LA, MI, MN, MO, NC, NM, NY, PA, SC, and TX and countries of Italy, France, Germany, and Finland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.