FDA Device recall Z-1285-2013
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects by Integra Lifesciences, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1285-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-28 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | 1125963, 1130387 1130386, 1130468 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1285-2013%22
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