90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/STR GRN 14MM, Rx, Sterile; 90597004117 Articular Surface CR ART SURF AE56/STR GRN 17MM, Rx, Sterile; 90597004120 Articular Surface CR ART SURF AE56/STR GRN 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Publicado el 28 de agosto de 2013 · Inicio del retiro: 7 de junio de 2013
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
Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Zimmer, Inc.
- Distribuidor
- Worldwide Distribution-USA (nationwide) and the country of Japan.
- Lote
- all codes
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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