Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
Publicado el 24 de julio de 2013 · Inicio del retiro: 31 de mayo 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
Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- Synthes USA HQ, Inc.
- Distribuidor
- US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.
- Lote
- Titanium Multi Vector Distractor Pin Holding Clamp, body, limited bone stock Part # 487.941 with lot numbers: 3769720, 3779569, 3788731, 3794434, 7806093, 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp, ramus, limited bone stock Part # 487.942 with lot numbers: 3769706, 3779571, 3788741, 7806096, 7823464.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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