Recall Z-1470-2020— Integra LifeSciences Corp.
Class III · Terminated
Class III FDA medical device recall by Integra LifeSciences Corp., initiated 2020-02-07, terminated 2020-06-10. It names one FDA 510(k) clearance: K011168. 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.. Reason: Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-02-07
- Terminated
- 2020-06-10
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.