The Recall Desk

FDA (Devices) recall action 69471

Instrumed International, Inc. recalled 28 products on 2014-12-17

The FDA (Devices) publishes a recall like this one as 28 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 28 pages.

Products
28
Announced
2014-12-17
Critical
0
Units
2,354

Why these products were recalled

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

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

26–28 of 28

  • LowFDA (Devices)··2014-12-17

    Instrumed Recalls Gardner-Wells Traction Tongs for Regulatory Compliance

    Instrumed International is withdrawing 190 Gardner-Wells traction tongs because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss…
    Category
    Distribution
    12 states
  • LowFDA (Devices)··2014-12-17

    Instrumed Recalls Zipser Meatus Clamps Due to Regulatory Non-Compliance

    Instrumed International is withdrawing 81 Zipser Meatus Clamps because the company did not market the devices prior to 1976, failing to meet FDA requirements for pre-amendment devices.

    Product
    A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
    Category
    Distribution
    12 states
  • LowFDA (Devices)··2014-12-17

    Instrumed Recalls Hudson Cranial Drill Sets for Regulatory Non-Compliance

    Instrumed International is withdrawing five Hudson cranial drill sets because the company failed to meet FDA requirements for marketing pre-amendment devices.

    Product
    Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.
    Category
    Distribution
    12 states