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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-27-04-25-873
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
CODMAN® Disposable Perforator 14mm and CODMAN® Craniotomy Kit containing Disposable Perforator 14mm
الأجهزة المتأثرة
Manufacturer's Product Number (Catalog #): 26-1221 Product Name (Description): CODMAN® Disposable Perforator 14mm UDI Number: 10381780513599 Lot Number (DD-MM-YY): Lot numbers with manufacturing dates between 27-07-2022 to 12-07-2024 Expiration Date (DD-MM-YY) : 30-06-2027 to 30-06-2029 Manufacturer's Product Number (Catalog #): 26-1230 Product Name (Description): CODMAN® Craniotomy Kit containing Disposable Perforator Cranio-blade Wire Pass Drill 14mm UDI Number: 10381780513629 Lot Number (DD-MM-YY): Lot numbers with manufacturing dates between 24-05-2023 to 28-05-2024 Expiration Date (DD-MM-YY) : 30-04-2028 to 30-04-2029 The impacted lots were distributed between July 5, 2023, through September 27,2024. Only specific lots distributed within this date range are impacted. The full list of impacted lot numbers are listed in the attachment.
الممثل المعتمد
Farouk Mamoun Tamer and Co
سبب المشكلة
An inadequate weld (proud weld) on specific lots of 14mm Codman® Disposable Perforators that can potentially cause the product to disassemble (break/separate) during its use.
الإجراء التصحيحي
Quarantine the affected units immediately and return them to Integra, refer to the attachment for more details. Manufacturer action: Removal.
المرفقات
عودة للقائمة
