The Recall Desk

FDA (Devices) recall action 67146

The Anspach Effort, Inc. recalled 4 products on 2014-01-22

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2014-01-22
Critical
0
Units
114,248

Why these products were recalled

Some carbide cutting burr fractured during use.

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

1–4 of 4

  • SevereFDA (Devices)··2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The products are intended for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The recall covers 28,562 units distributed worldwide.

    Product
    Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling carbide cutting burrs and drums because some fractured during use. The products are used for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The devices are intended for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide…
    Category
    Distribution
    1 state