The Recall Desk

FDA (Devices) recall action 67885

Acumed LLC recalled 2 products on 2014-05-07

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
2014-05-07
Critical
0
Units
—

Why these products were recalled

Manufacturing of these devices with a grade of stainless steel that is not within specifications.

Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-05-07

    Acumed Osteo-Clage System Recalled for Non-Specification Stainless Steel

    Acumed LLC is recalling the Osteo-Clage System because the stainless steel used in manufacturing was not within specifications.

    Product
    The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression p
    Category
    Distribution
    17 states
  • HighFDA (Devices)··2014-05-07

    Acumed Recalls Tension Band Pins Due to Steel Specification Defect

    Acumed LLC is recalling specific lots of Tension Band Pins because they were manufactured with stainless steel that does not meet specifications.

    Product
    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Num
    Category
    Distribution
    17 states