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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1796-2012

Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.

Publicado el 20 de junio de 2012 · Inicio del retiro: 11 de octubre de 2011

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

The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Integra LifeSciences Corp.
Distribuidor
Worldwide Distribution
Lote
Putty Part Number 7700713001 510 K- K062353 Device Listing Number - E604163 Integra MOZAIKTM Putty 2.5cc Reference No. - PTY10125ITL Batch number - 105BR02l5949 Integra MOZAIKTM Putty 5cc Refernce No. - PTY10155ITL Batch No. - 105BR0216024 Integra MOZAIKTM Putty lOcc Reference No.- PTY10210ITL Batch No. - 105BR0215956
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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