The Recall Desk

FDA (Devices) recall action 73561

Synthes (USA) Products LLC recalled 2 products on 2016-04-13

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-04-13
Critical
0
Units
—

Why these products were recalled

Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.

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

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, potentially compromising the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and sel
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, which may affect the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and sel
    Category
    Distribution
    12 states