FDAFDA · Alimentos y medicamentos·N.º oficial Z-2475-2012
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 10 de octubre de 2012 · Inicio del retiro: 1 de abril de 2011
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
Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Zimmer, Inc.
- Distribuidor
- Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
- Lote
- All lots distributed from lot 69998600 (2/20/1996) to present
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States