Recall Z-1287-2013 ยท JXI Cuff, Nerve
Integra LifeSciences Corporation
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.
| Date | May 10, 2013 (initiated Mar 28, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | The firm, Integra, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 9, 2013, to all US, Canada, and non-EU Integra consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify if they have any lots of the listed product, if so, STOP using that product; remove the product from service; and promptly complete and return the PRODUCT RECALL RETURN ACKNOWLEDGMENT FORM via Email: FCA@integralife.com or FAX to : 1-609-275-9445. Customer Service department will contact you to return and replace the product. "However, if y |
| Quantity | 1,661 boxes |
| Distribution | Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011168 | NEUROGEN NERVE GUIDE Integra Lifesciences Corp., Jun 22, 2001 |