The Recall Desk

FDA (Devices) recall action 75858

Amendia, Inc recalled 3 products on 2016-12-28

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
2016-12-28
Critical
0
Units
7,151

Why these products were recalled

The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

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

1–3 of 3

  • ModerateFDA (Devices)··2016-12-28

    Amendia Savannah-T Straight Rods Recalled for Packaging Seal Defects

    Amendia, Inc. is recalling Savannah-T Straight Rods because some packages have unacceptable seals with compromised integrity.

    Product
    Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight
    Category
    Distribution
    26 states
  • LowFDA (Devices)··2016-12-28

    Amendia Recalls K-Wires Due to Unacceptable Packaging Seals

    Amendia, Inc. is recalling 5,833 units of K-Wires because the packaging seals are unacceptable, with some showing compromised integrity due to channels or voids.

    Product
    K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inc
    Category
    Distribution
    26 states
  • ModerateFDA (Devices)··2016-12-28

    Amendia Dual Stylet Needle Recall Due to Unacceptable Packaging Seals

    Amendia, Inc. is recalling 1,078 Dual Stylet Needles because packaging seals are compromised by channels or voids, potentially affecting product integrity.

    Product
    Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
    Category
    Distribution
    26 states