Manufacturers

Materialise USA LLC

7 dispositivos en la base de datos

Device Recall Signature Personalized Patient Care System
  • Modelo / Serial
    Lot #154970
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    One consignee, Indiana.
  • Descripción del producto
    Signature TKA GDE/MDL Set 04-05 || Patient-specific surgical guide and instrument set.
Device Recall LPSFlex Pin Guides
  • Modelo / Serial
    Lot 56529819, REF 005970-000-02 Exp 2012-09-06
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including the states of Ohio and Minnesota.
  • Descripción del producto
    PATIENT SPECIFIC INSTRUMENTS || LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) || NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE || Patient ID--0242-LF || Manufactured by Materialise, Plymouth, MI || Distributed by Zimmer, Warsaw IN. || Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
Device Recall NK Flex Pin Guides
  • Modelo / Serial
    Lot 56529886, REF 005970-000-03 Exp 2012-09-08
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including the states of Ohio and Minnesota.
  • Descripción del producto
    PATIENT SPECIFIC INSTRUMENTS || N-K FLEX PIN GUIDES (FEMUR AND TIBIA) || NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE || Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI || Distributed by Zimmer, Warsaw IN. || Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
Device Recall ProPlan CMF
  • Modelo / Serial
    Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01
  • Distribución
    Distributed in Canada.
  • Descripción del producto
    ProPlan CMF Guide(s) Model(s) || REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. || Used as surgical tools to transfer a pre-operative plan to surgery.
Device Recall ProPlan CMF
  • Modelo / Serial
    Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2
  • Distribución
    Distributed in Canada.
  • Descripción del producto
    ProPlan CMF Guide(s) Model(s) || REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. || Used as surgical tools to transfer a pre-operative plan to surgery. || .
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