Z-1285-2013 Class II Terminated
FDA device recall Z-1285-2013 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: 52 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
- 52 boxes
Product Description
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes.
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
1125963, 1130387 1130386, 1130468