Integra LifeSciences Corp. recalls NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated fo…

Recall date

February 7, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1470-2020

FDA classification

Class III

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

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.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.