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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-05-12-24-699
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Sterile Percutaneous Reference Pin
الأجهزة المتأثرة
Product Name (Manufacturer’s Catalog Number, GTIN, Lot Number): Sterile Percutaneous Reference Pin, 100mm (9733235, 00613994247872, 2023101139) Sterile Percutaneous Reference Pin, 150mm (9733236, 00613994247865, 2023101142)
الممثل المعتمد
Medtronic Saudi Arabia LLC
سبب المشكلة
Certain percutaneous pin lots have been identified as having the potential for an out of round diameter, that may render the percutaneous pin unable to fit into the Patient Reference Frame (9732353) or Percutaneous Pin Adapter (9734752). This issue is associated with specific lots of the Percutaneous Pin used during spinal surgeries.
الإجراء التصحيحي
Medtronic requests that you immediately take the following actions: 1. Immediately locate and quarantine all unused impacted product(s). 2. Return unused impacted product(s) to Medtronic representative, refer to the attachment for more information. Manufacturer Action: Removal.
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