FDAFDA · Alimentos y medicamentos·N.º oficial Z-1283-2013
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.
Publicado el 22 de mayo de 2013 · Inicio del retiro: 28 de marzo de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Integra LifeSciences Corporation
- Distribuidor
- 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.
- Lote
- 1125682, 1125681 1125817, 1125983, 1126018 1126019, 1130641 1130642, 1110848, 1110849 1111883, 1111354, 1111884 1111936, 1112151 1110256, 1111355
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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