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الأحد - رجب 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-11-12-25-1177
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ZIMMER DERMATOME AN Dermatome AN Handpiece
الأجهزة المتأثرة
Material Number | Material Description | GTIN Number 00-8801-001-00 | Zimmer® Air Dermatome | 00889024375901 88710100 | Zimmer® Dermatome AN | 00889024484834 Please refer to the attachment for Serial Numbers
الممثل المعتمد
Zimmer Biomet Asel Alarabia Limited
سبب المشكلة
Multiple product complaints have been received related to Air Dermatome devices that were cutting beyond the proper depth. Inspections of the returned product complaint devices confirmed that affected devices may have a misaligned thickness control bar.
الإجراء التصحيحي
Customers will be contacted by Zimmer Biomet representative to return their affected products. Due to the likelihood that the issue would occur upon the first few uses, affected devices that have not exhibited the issue may continue to be used until the customers are contacted by Zimmer Biomet representative for product removal. Manufacturer action: Removal.
المرفقات
عودة للقائمة