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| M/L Taper Hip Prosthesis with Kinective Technology--Courtesy of Zimmer |
The FDA added three Class 1 recalls to its database this week, reserved for situations in which the agency believes there is a reasonable probability that exposure to the faulty device "will cause serious adverse health consequences or death."
Zimmer's ($ZMH) recall of a component of its total hip replacements received the undesirable designation due to "higher than allowed cytotoxicity levels found with the product" that result in a "reasonable probability of adverse biological response and subsequent revision," the FDA said in its recall database.
The database shows that the recall is the first to be designated Class 1 among corrective actions of semiconstrained, metal, and uncemented hip prosthesis acetabular components.
A total of 752 units of the M/L Taper Hip Prosthesis with Kinectiv Technology were recalled in various U.S. states and other countries in North America, Europe and Asia. Zimmer sent a letter to affected customers in May instructing them to quarantine and return the affected products, which were manufactured in Warsaw, IN, where the company is headquartered.
In the device's guide, Zimmer says the metal, uncemented component "is designed to facilitate an accurate and stable biomechanical reconstruction of the hip joint with modular stem and neck components. The individual neck and stem provides numerous options to independently control leg length, femoral offset, version and proximal stem fit."
In addition, the implant is supposed to facilitate insertion and assembly of the hip replacement during minimally invasive procedures, which are now in high demand because they are associated with faster patient recovery.
Meanwhile, Germany's Maquet Holdings continues to get hammered by the feds. Earlier this year the Department of Justice dealt it a permanent injunction that resulted in the cessation of manufacturing at one of its facilities, the suspension of 5 of its devices from the market and a $6 million fine.
This week the FDA disclosed the recall of its Flow-i anesthesia administration system and put it in the most severe category. More than 1,600 units of the device suffer from a potential gas leak that could stop patient ventilation. The company sent a letter to customers in May, in which it said it would replace the faulty component.
In April the FDA announced a Class 1 recall of all 4,154 units of Maquet's stroke-fighting TigerPaw System II left atrial appendage closure device.
Finally, the FDA deemed HeartWare's ($HTWR) previously described "urgent medical device correction" about the proper use and potential problems associated with its flagship bridge to heart transplantation device as a Class 1 recall. The letter describes 5 known safety and usability issues of the Ventricular Assist System and tells customers how to handle them.
The company has now been hit with four Class 1 recalls of the Ventricular Assist System since April 2014.
All of the recalls are being conducted by the companies on a voluntary basis. Not all recalls involve returning or replacing the affected device. The companies are required to tell the FDA about corrective actions, which the agency then publicizes and classifies in its recall database.
- read the notice about the Zimmer recall
- read the notice about the Maquet recall
- read the notice about the HeatWare recall
Editor's Note: A paragraph about other manufacturers of hip implants who also experienced recalls was removed at the request of Biomet. FierceMedicalDevices determined that the classification scheme used by the FDA is too broad and contains many hip-related devices that are not similar to the M/L Taper Hip Prosthesis. Biomet does not does not market a modular neck component.