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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1325-2021

PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

Publicado el 7 de abril de 2021 · Inicio del retiro: 12 de febrero de 2021

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Nuvasive Specialized Orthopedics Inc
Distribuidor
Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Luxemburg, Netherlands, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey and UAE. Consignee List provided only includes email addresses. Complete contact information is pending.
Lote
All Lots affected. Below are: Primary DI Number(GTIN)/Product Code (REF)/Product Description: 00887517021915 LP4.5-DLF30 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 0-Hole; 00887517021908 LP4.5-DLF31 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 1-Hole; 00887517021892 LP4.5-DLF32 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 2-Hole; 00887517021885 LP4.5-DLF3B PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, Bump; 00887517021878 LP4.5-DLF40 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 0-Hole; 00887517021861 LP4.5-DLF41 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 1-Hole; 00887517021854 LP4.5-DLF42 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 2-Hole; 00887517021847 LP4.5-DLF4B PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, Bump; 00887517021830 LP4.5-DRF30 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 0-Hole; 00887517021823 LP4.5-DRF31 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 1-Hole; 00887517021816 LP4.5-DRF32 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 2-Hole; 00887517021809 LP4.5-DRF3B PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, Bump; 00887517021793 LP4.5-DRF40 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 0-Hole; 00887517021786 LP4.5-DRF41 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 1-Hole; 00887517021779 LP4.5-DRF42 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 2-Hole; 00887517021762 LP4.5-DRF4B PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, Bump; 00887517021755 LP4.5-MLT30 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 0-Hole; 00887517021748 LP4.5-MLT31 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 1-Hole; 00887517021731 LP4.5-MLT32 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 2-Hole; 00887517021724 LP4.5-MLT3B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, Bump; 00887517021717 LP4.5-MLT40 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 0-Hole; 00887517021700 LP4.5-MLT41 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 1-Hole; 00887517021694 LP4.5-MLT42 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 2-Hole; 00887517021687 LP4.5-MLT4B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, Bump; 00887517021670 LP4.5-MRT30 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 0-Hole; 00887517021663 LP4.5-MRT31 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 1-Hole; 00887517021656 LP4.5-MRT32 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 2-Hole; 00887517021649 LP4.5-MRT3B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, Bump; 00887517021632 LP4.5-MRT40 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 0-Hole; 00887517021625 LP4.5-MRT41 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 1-Hole; 00887517021618 LP4.5-MRT42 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 2-Hole; 00887517021601 LP4.5-MRT4B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, Bump; 00887517021595 LP4.5-PLF30 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 0-Hole; 00887517021588 LP4.5-PLF31 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 1-Hole; 00887517021571 LP4.5-PLF32 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 2-Hole; 00887517021564 LP4.5-PLF3B PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, Bump; 00887517021557 LP4.5-PLF40 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 0-Hole; 00887517021540 LP4.5-PLF41 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 1-Hole; 00887517021533 LP4.5-PLF42 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 2-Hole; 00887517021526 LP4.5-PLF4B PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, Bump; 00887517021519 LP4.5-PLT30 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 0-Hole; 00887517021502 LP4.5-PL
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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