ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Publicado el 11 de julio de 2012 · Inicio del retiro: 16 de mayo 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
DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- DePuy Orthopaedics, Inc.
- Distribuidor
- Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
- Lote
- Product code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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