The Recall Desk

FDA (Devices) recall action 75869

Amendia, Inc recalled 2 products on 2016-12-28

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
2016-12-28
Critical
0
Units
144

Why these products were recalled

There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.

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.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2016-12-28

    Amendia Recalls Black Widow Spinal Screws Due to Mating Feature Defect

    Amendia, Inc. is recalling 96 units of Black Widow 6.6mm spinal screws due to a design defect in the mating feature between the plate and screw.

    Product
    Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2016-12-28

    Amendia Recalls Black Widow Spinal Plates Due to Mating Feature Defect

    Amendia, Inc. is recalling 48 units of Black Widow Buttress Plates due to a design defect in the mating feature between the plate and screw.

    Product
    Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
    Category
    Distribution
    3 states