Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable… — Class II medical device recall Z-1282-2013
Terminated recall by Integra LifeSciences Corporation, reported 2013-05-22, distributed nationwide. Due to the process deviation, product lots in question may have been released with higher levels of pyrogens t
| Recall number | Z-1282-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corporation, Plainsboro, NJ, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2013-05-10 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2015-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, CA, CL, CN, CR, DK, EG, ES, FR, GB, IT, JP, PE, SG, TH, ZA |
| Quantity | 15,607 boxes |
| Reason classes | sterility |
Product
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1282-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.