The Recall Desk

FDA (Devices) recall action 87353

Nuvasive Specialized Orthopedics Inc recalled 3 products on 2021-04-14

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-04-14
Critical
0
Units
10,945

Why these products were recalled

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2021-04-14

    Nuvasive Precice Unyte Orthopedic Rods Recalled for Missing Biological Assessments

    Nuvasive Specialized Orthopedics is recalling Precice Unyte orthopedic trauma nails because they lack full biological assessments and are not indicated for patients under 18.

    Product
    NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic traum
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-04-14

    Nuvasive Freedom End Caps Recalled for Missing Biological Assessments

    Nuvasive Specialized Orthopedics Inc. is recalling 59 units of Freedom End Caps and related components because they lack full biological assessments and are not indicated for patients under 18.

    Product
    NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Pa
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-04-14

    Nuvasive PRECICE Limb Lengthening System Recalled for Missing Biological Assessments

    Nuvasive Specialized Orthopedics is recalling PRECICE limb lengthening devices because they lack full biological assessments and are not indicated for patients under 18.

    Product
    NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/
    Category
    Distribution
    0 states
Nuvasive Specialized Orthopedics Inc recalled 3 products on 2021-04-14 · The Recall Desk