Recall Z-1284-2013— 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: K032693. Product: DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.. 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
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.