Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural… — Class II medical device recall Z-1283-2013
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-1283-2013 |
|---|---|
| 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 |
| Reason classes | sterility |
Product
Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.
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-1283-2013. 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.