FDAFDA · Alimentos y medicamentos·N.º oficial Z-2054-2013
Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.
Publicado el 4 de septiembre de 2013 · Inicio del retiro: 30 de julio 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
Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause foreign body reaction including inflammation and might lead to the need for revision surgery.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Craniomaxillofacial Division
- Distribuidor
- Worldwide Distribution - USA (nationwide) including the countries through Stryker Distribution: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Spain, Sweden, Switzerland, United Kingdom, Argentina, Australia, Brazil, Jordan, Kingdom of Saudi Arabia, Kuwait, Latin America (others), New Zealand, Russia, Singapore, South Africa, and United Arabian Emirates.
- Lote
- Part 79-43903, Lot: IC01116, IC01130, IC01204, IC01233, IC01238 Part 79-43905 Lot: IC01084, IC01085, IC01086, IC01093, IC01123, IC01150, IC01166, IC01167, IC01168, IC01180, IC01188, IC01189, IC01190, IC01198, IC01199, IC01200, IC01213, IC01214, IC01229, IC01230, IC01239, IC01240, IC01245, IC01246, IC01270 Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154, IC01163, IC01164, IC01165, IC01179, IC01183, IC01184, IC01201, IC01202, IC01203, IC01231, IC01243, IC01244, IC01248, IC01249, IC01261, IC01264, Part 79-43015 Lot: IC01100, IC01114, IC01161, IC01162, IC01182, IC01211, IC01212, IC01227, IC01228, IC01241, IC01242, IC01252, IC01253, IC01254, IC01267 Part 397003 Lot: IC01092, IC01101, IC01102, IC01103, IC01104, IC01105, IC01106, IC01107, IC01115, IC01127, IC01131, IC01205, IC01220, IC01232, IC01234 Part 397005 Lot: IC01088, IC01094, IC01095, IC01096, IC01097, IC01098, IC01110, IC01111, IC01118, IC01119, IC01120, IC01132, IC01133, IC01134, IC01135, IC01136, IC01137, IC01147, IC01148, IC01149, IC01158, IC01159, IC01160, IC01171, IC01172, IC01181, IC01193, IC01194, IC01195, IC01196, IC01223, IC01224, IC01247Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154 Part 397010 Lot: IC01099, IC01108, IC01109, IC01112, IC01121, IC01138, IC01139, IC01140, IC01141, IC01151, IC01152, IC01155, IC01156, IC01157, IC01173, IC01174, IC01191, IC01192, IC01197, IC01210, IC01216, IC01219, IC01225, IC01226, IC01250, IC01251, IC01263, IC01266, IC01301 Part 397015 Lot: IC01113, IC01122, IC01124, IC01125, IC01142, IC01143, IC01144, IC01145, IC01146, IC01169, IC01170, IC01177, IC01178, IC01185, IC01186, IC01187, IC01206, IC01207, IC01208, IC01209, IC01217, IC01218, IC01221, IC01222, IC01265
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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