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.
Reported: March 18, 2020 Initiated: February 7, 2020 #Z-1470-2020
Product Description
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.
Reason for Recall
Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 55
- Distribution
- 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.
- Location
- Princeton, NJ
Frequently Asked Questions
What product 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.. Recalled by Integra LifeSciences Corp.. Units affected: 55.
Why was this product recalled? ▼
Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 18, 2020. Severity: Low. Recall number: Z-1470-2020.
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