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Rappel de Device Recall AOS Trochanteric Nail
Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Advanced Orthopaedic Solutions Inc.
Qu'est-ce que c'est?
Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.
En savoir plus sur les données ici-
Type d'événement
Recall
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ID de l'événement
54538
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Classe de risque de l'événement
Class 2
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Numéro de l'événement
Z-1191-2010
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Date de mise en oeuvre de l'événement
2010-01-14
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Date de publication de l'événement
2010-03-22
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Statut de l'événement
Terminated
- Pays de l'événement
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Date de fin de l'événement
2012-04-26
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Source de l'événement
USFDA
- URL de la source de l'événement
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Notes / Alertes
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records. -
Notes supplémentaires dans les données
rod, fixation, intramedullary and accessories - Product Code HSB
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Cause
The recall was initiated after advanced orthopaedic solutions (aos) became aware of a manufacturing defect involving the short trochanteric nail, where one piece was found to be incorrectly bent. if this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.
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Action
The recall was initiated with the firm forwarding a recall notice with attached customer response form on January 14, 2010 to the affected consignees. The recall notice informed the consignees of the reason for recall and gave them three steps to follow to inspect the affected Short Trochanteric Nail products. Consignees were provided with product return instruction for any incorrectly bent products found during their inspection. Customers with questions are instructed to contact the firm at (310) 533-9966.
Device
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Modèle / numéro de série
Lot Number: 09023.
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
Yes
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Distribution
Nationwide and Japan
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Description du dispositif
AOS Trochanteric Nail, 10mm x 20cm x 135¿, Product Part Number: 1042-200.
- Manufacturer
Manufacturer
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Adresse du fabricant
Advanced Orthopaedic Solutions Inc, 386 Beech Ave, Torrance CA 90501
- Société-mère du fabricant (2017)
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Source
USFDA