Stryker Corporation’s Instruments division has initiated a worldwide, Class 1 recall of 23 Operating Room System II Surgical Navigation Systems. A Class 1 recall is the U.S. Food & Drug Administration’s (FDA) most serious type of recall, and involves situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

The Navigation System II is a computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures. The Navigation System II cart contains a computer workstation with the navigation System II software and various components necessary to run the system. More Stryker Corp. Recalls Operating Room System II Surgical Navigation Systems

Synthes USA is recalling all lots of the Ti Synex II Vertebral Body Replacement device. The U.S. Food & Drug Administration (FDA) has deemed the Synthes USA Ti Synex II Vertebral Body Replacement recall a Class I recall.

The Ti Synex II Vertebral Body Replacement is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. The recall is being issued because of reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ occurring at six to fifteen months post implantation. More Synthes USA Issues Class I Recall for Vertebrae Replacement Implants

Edwards Lifesciences Corporation has issued a recall of CardioVations EndoClamp Aortic Catheter. The Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious type of recall.

The CardioVations EndoClamp Aortic Catheter locks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. According to the recall notice, the balloon catheters may spontaneously rupture during surgery. More Edwards Lifesciences Recalls Aortic Catheters

Cordis Corporation is recalling all lots of the Crossover Sheath Introducer due to complaints about stretching or fracture of the sheath during use.

To date, Cordis has received six complaints about the Crossover Sheath Introducer. No permanent patient injuries have been reported. In two instances, successful surgical intervention was performed to retrieve a portion of the sheath. More Cordis Recalls Crossover Sheath Introducer

A voluntary nationwide recall was issued yesterday for all Accusure® Insulin Syringes manufactured by Qualitest Pharmaceuticals of Huntsville, Alabama.

The recalled syringes may have needles which detach from the syringe. According to the recall notice, if the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. More Qualitest Pharmaceuticals Issues Recall For All Accusure® Insulin Syringes

Certain units of the single-patient use Manual Pulmonary Resuscitator (MPR) have been recalled by Unomedical Inc. This recall is being conducted because of a potential malfunction of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death.

Pulmonary resuscitators are used to administer artificial respiration to a patient while also giving an external cardiac massage. They are used during CPR to resuscitate patients suffering from cardiac arrest, and resuscitators use positive pressure to inflate the lungs of the patient while they are not breathing, in order to keep them oxygenated. More Unomedical Recalls Manual Pulmonary Resuscitators

Accu-Check Spirit insulin pumps are being recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the “up” and/or “down” buttons of some devices. According to the recall notice, if the buttons do not function, users may not be able to change any programmed setting on the Accu-Check Spirit insulin pumps.

“We are making this proactive notification to our customers and other interested parties because we have seen a potential for the “up” and/or “down” buttons on some of our pumps to fail over a period of use,” Dr. Mathias Neumann, Head of Global Quality Management Diabetes Care, Roche Diagnostics, said in a statement released by the company. “We are telling our customers to continue to use their ACCU-CHEK Spirit insulin pumps, but monitor the functioning of the “up” and “down” buttons. In addition customers are to continue to monitor their blood glucose as directed by their healthcare professional.”

The recall involves Accu-Check Spirit insulin pumps with serial numbers in the range from SN02119552 through SN10006093 (US market). The potentially defective buttons are used to override pre-programmed settings or to deliver an additional bolus dose of insulin.

To determine if an Accu-Check Spirit insulin pump is defective, patients should test the up and down buttons to see if they can change the programmed setting on the pump. Defective pumps may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. If such a signal doesn’t occur, the user should disconnect the pump and switch to a back-up pump or an alternative method of insulin delivery, and immediately call the Accu-Check hotline for a replacement pump.

Customers should expect a replacement pump within 1-2 business days after contacting Accu-Check Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week.

According to the recall notice, the root cause of the defect has been identified. The problem is an interrupted electronic contact in the flexible board of the “up” and “down” button module caused over time by stress of this board during repeated pressing of the button. A fix to the problem has been implemented for Accu-Check Spirit insulin pumps with SN10006094 and above.

Pumps with serial numbers including and above SN10006094 are not affected and no action is required by users of these pump.The Pink Panther the movie

A class I recall has been issued for Medtronic BioGlide Ventricular Shunt Catheters. A class I recall is issued when a device poses a risk of serious injury and death.

The recalled Medtronic BioGlide Ventricular Shunt Catheter is part of a system used to treat a condition called hydrocephalus, which is characterized by an excessive accumulation of fluid in the brain. While hydrocephalus occurs in adults, it is most common in children. More Medtronic Recalls BioGlide Ventricular Shunt Catheters

A simple medical device called the Calaxo Bone Screw has been causing a great deal of pain and suffering for those who have undergone Anterior Cruciate Ligament (ACL) reconstructive surgery. The Calaxo Bone Screw was recalled in August 2007 due to reports of serious complications. Some patients even had to have repeat surgeries to have the Calaxo Bone screw replaced.

The ACL, which runs from the tibia, or shin bone, through the knee joint and to the femur or thigh bone, helps stabilize the knee and control front-to-back movement. ACL tears are most frequent among athletes who participate in sports such as soccer or skiing that require them to jump or change direction quickly and frequently. More Calaxo Bone Screw Causing Painful Complications for ACL Surgery Patients

Welch Allyn has issued a worldwide recall of various AED 10 and MRL JumpStart automatic external defibrillators manufactured between October 3, 2002 and January 25, 2007. The Food & Drug Administration (FDA) has deemed the Welch Allyn defibrillator recall a Class I recall because there is a reasonable probability that use of the product will cause serious injury or death.

According to the FDA, the recalled Welch Allyn defibrillators are used by emergency or medical personnel, or by others who have completed CPR AED training courses. The devices are intended to treat adults who are having a heart attack. The device analyzes an unconscious patient’s heart rhythm and automatically delivers an electrical shock to the heart if needed to restore a normal heart rhythm. More Welch Allyn Recalls Automatic External Defibrillators