Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Publicado el 8 de agosto de 2012 · Inicio del retiro: 15 de junio de 2012
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
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Exactech, Inc.
- Distribuidor
- Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.
- Lote
- Catalog Number 324-11-00 Serial Range 1653706-2381151
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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