Z-1470-2020 Class III Terminated
FDA device recall Z-1470-2020 was initiated by Integra LifeSciences Corp. on February 7, 2020 and is designated Class III. Reason for recall: Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. The recall status is terminated (terminated June 10, 2020). Affected quantity: 55.
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2020
- Initiation Date
- February 7, 2020
- Termination Date
- June 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55
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.
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.
Code Information
Lot # 3388360