Z-1287-2013 Class II Terminated
FDA device recall Z-1287-2013 was initiated by Integra LifeSciences Corporation on March 28, 2013 and is designated Class II. 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. The recall status is terminated (terminated June 3, 2015). Affected quantity: 1,661 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- March 28, 2013
- Termination Date
- June 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,661 boxes
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.
Distribution Pattern
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.
Code Information
1105457 1112377, 1112378 1112103 1112106, 1112003, 1112296, 1110715 1112052, 1112004, 1112030 1111972 1112376