The Recall Desk

FDA (Devices) recall action 67131

The Anspach Effort, Inc. recalled 2 products on 2014-01-15

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
2014-01-15
Critical
0
Units
—

Why these products were recalled

Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-01-15

    Anspach Craniotome Recalled After Use in Creutzfeldt-Jakob Disease Case

    The Anspach Effort, Inc. is recalling specific craniotome attachments used in a case involving a patient with Creutzfeldt-Jakob Disease.

    Product
    Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2014-01-15

    Anspach BLACKMAX-N Pneumatic Motor Recalled for CJD Exposure Risk

    The Anspach Effort, Inc. is recalling four BLACKMAX-N pneumatic motors and one Autolube III foot control used in a case involving a patient with Creutzfeldt-Jacob Disease.

    Product
    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
    Category
    Distribution
    1 state