LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER 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:152180009 and Lot numbers: AE9GG1000, AH7DW1000, U5TA2C000, V1YEE1001, W1CBL1001, W5RF41001, W5RF41007, and Y84DW1000.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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