FDAFDA · Alimentos y medicamentos·N.º oficial Z-0578-2016
BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.
Publicado el 13 de enero de 2016 · Inicio del retiro: 12 de noviembre de 2015
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
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Corflex
- Distribuidor
- Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
- Lote
- (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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