Synthes USA Vertebral Body Replacement – Recall From the FDA to Stop Implanting Immediately

This is a class one recall, the most serious type. I’m adding it here in case it is missed anywhere else. The picture shown is from the company website and may not be representative of the exact device being recalled. Hopefully the notice will be found by all involved. This brings me back around once more to a post I made back in October, what if this is missed and someone ends up with a recalled implant? I did a post about a man who died who was implanted with a device that had been recalled, a hip replacement device.

Tracking Medical Device Recalls – Sounds Like A Good Place for a Microsoft Tag Data Base at the FDA

Actually I sent this off to the FDA to use Windows Tags to scan medical devices before they are used in surgery. This is done with any smartphone, BlackBerry, IPhone, etc. The software is free and consumers could use it too and it would give the FDA a data base to easily research for recall notices. So far I have not heard anything, but maybe in light if this recall, perhaps Synthes might take a look as it would certainly give an instant avenue of information on a recalled device. All a manufacturer has to do is put the 2D tag on their packaging. You can read more at the link above. The tag looks like the image below, which by the way works. Try it with your phone.

There’s no expense to a hospital or doctor to use a phone to scan the device, so what are they waiting for, more to die due to the fact that the FDA does not have system to ensure recalled devices are not used? This solution is free and just so very simple, so what is the FDA waiting for? This recall represents 2 years worth of product and shipped as late as September 2009, a couple months ago. BD

November 13, 2009 — The US Food and Drug Administration (FDA) issued a class I recall yesterday of all lots of the Ti Synex II Vertebral Body Replacement (Synthes USA), the agency announced. The device is used in the T1–L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body.

The recall applies to products manufactured from June 8, 2007 to September 9, 2009, and distributed from July 2, 2007 to September 8, 2009. Part numbers affected include 04.808.001 to 04.808.011, Synex II Central Body, Titanium (all lots).

According to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program, moderate to severe loss of vertebral body replacement height, caused by failure of the device's central body component, within 6 to 15 months of implant has been reported. As of September 14, 2009, 6 adverse event reports had been received. The company notified hospitals and sales consultants about this recall by mail on September 23, 2009.

"Surgeons and hospitals in possession of the subject devices must stop implanting them immediately," the alert warns. "Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery."

Those with questions can call the company at 1-800-620-7025, extension 5375, between 8:30 am and 4:30 pm ET, Monday through Friday.

More information is available on the FDA's MedWatch Web site.