FDAFDA · Alimentos y medicamentos·N.º oficial Z-1191-2017
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur.
Publicado el 22 de febrero de 2017 · Inicio del retiro: 10 de enero de 2017
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
Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Encore Medical, Lp
- Distribuidor
- US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
- Lote
- 1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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