Recall Z-1287-2013— Integra LifeSciences Corporation
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corporation, initiated 2013-03-28, terminated 2015-06-03. It names one FDA 510(k) clearance: K011168. Product: NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.. Reason: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products..
- Recalling firm
- Integra LifeSciences Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-28
- Terminated
- 2015-06-03
- Firm location
- Plainsboro, 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 NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Reason for recall
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Data sourced from openFDA. This site is unofficial and independent of the FDA.