تسجيل الدخول
تسجيل جديد
الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-28-08-25-1029
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
CARTIVA® Synthetic Cartilage Implant
الأجهزة المتأثرة
Please refer to Catalogue Numbers in the attachment.
الممثل المعتمد
Cure Development Ltd
سبب المشكلة
Cartiva SCI devices have been observed in some cases to be revised/removed at higher rates than previously observed in the initial Cartiva SCI premarket and post-approval studies.
الإجراء التصحيحي
Customers are requested to complete the following actions: - Check your internal inventory to locate the products listed in the attachment, remove them from their point of use, isolate/ quarantine the unit(s), and contact the local stryker representative to arrange for the return of the affected products. - Continue to follow patients treated with an impacted product by following "Patient recommendation" in the attachment. Manufacturer Action: Instructions and removal.
المرفقات
عودة للقائمة
