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Instrumed International Recalls
38 recalls on record · October 8, 2014 to December 17, 2014 · Medical Devices
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by appl
Hazard: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye
Hazard: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's sku
Hazard: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's sku
Hazard: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine
Hazard: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a pa
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervi
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and s
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's s
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sol
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and so
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and so
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant so
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patien
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of t
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Me
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the ut
Hazard: 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.
December 17, 2014Medical DevicesFDA
Instrumed International, Inc. recalls A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Tel
Hazard: 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.
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
October 8, 2014Medical DevicesFDA
Instrumed International, Inc. recalls Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to
Hazard: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.