. 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
Publicado el 28 de noviembre de 2012 · Inicio del retiro: 10 de octubre de 2010
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
Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Zimmer, Inc.
- Distribuidor
- Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
- Lote
- All lots distributed from lot 69998600 (2/20/1996) to present
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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