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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0776-2014

Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.

Publicado el 22 de enero de 2014 · Inicio del retiro: 24 de septiembre de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Handles and heads may not be compatible.

Qué hacer

Voluntary: Firm initiated · E-Mail

Detalles del retiro

Fabricante
SpineFrontier, Inc.
Distribuidor
US Distribution: VA only.
Lote
CT128047, CT128048
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States