FDA-Device2020-03-18Class III
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.
Integra LifeSciences Corp.
Hazard
Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
Sold states
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.
Affected count
55
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1470-2020Don't want to check this manually?
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