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