FDAFDA · Alimentos y medicamentos·N.º oficial Z-1738-2015
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.
Publicado el 17 de junio de 2015 · Inicio del retiro: 6 de mayo de 2015
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
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Smith & Nephew, Inc.
- Distribuidor
- Worldwide Distribution - US Nationwide in the states of CA, FL, IL, IN, MI, NE, NY, TN, TX, VA, WI and the countries of Australia, Switzerland, Chile, Canada, and Spain
- Lote
- Lot numbers: 16HM08087, 14HM08097, 14HM08133, 14HM08141, and 14JM21517
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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