The Recall Desk

FDA (Devices) recall action 63157

Medtronic Sofamor Danek USA Inc recalled 3 products on 2012-10-17

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
2012-10-17
Critical
0
Units
2,308

Why these products were recalled

Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.

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

  • HighFDA (Devices)··2012-10-17

    Medtronic Atlantis Anterior Cervical Plate Screw Module Recall

    Medtronic is recalling Atlantis Anterior Cervical Plate System screw modules because gauge lines may be misplaced, leading to inaccurate screw length measurements.

    Product
    ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring functio
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-10-17

    Medtronic Premier Anterior Cervical Plate Screw Block Recall

    Medtronic is recalling 247 units of the Premier Anterior Cervical Plate System Screw Block because gauge lines may be misaligned, potentially causing screws to be measured as 1 mm shorter than their actual length.

    Product
    PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-10-17

    Medtronic Atlantis Anterior Cervical Plate Screw Module Recalled for Measurement Error

    Medtronic is recalling the Atlantis Anterior Cervical Plate System Variable Angle Screw Module because gauge lines may be misaligned, leading to inaccurate screw length measurements.

    Product
    ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring func
    Category
    Distribution
    0 states