Recall of medical devices

[MK1965]

This question came to my mind.
I work in healthcare and I am familiar with medical devices recall like pacemakers, titanium rods and other orthopedic hardware, picc lines for continued antibiotics administration, facial implants for facial fractures fixation etc.
I am wondering if AMS and Coloplast had recall any of their penile implants.
Anyone ever heard of it?
MK

[Lost Sheep]

I don't know if the AMS Ultrex every had any recalls, but it is no longer on the market.

It may have suffered from design flaws, or simply an artifact of surgeons' "learning curve" on implanting a length-expanding prosthetic. I do not know.

[Biker60]

FDA.gov and search medical device recalls

[b_rad2]

I have a friend that is a very successful medical malpractice attorney. The reality of getting a judgement against any implant manufacturer is very tough and expensive.

She said that the very first cases she worked (large law firm) on was representing one of the two manufacturers we discuss here on a daily basis. (FYI; she said it was a two part inflatable implant). That was thirty years ago. More times than not the device manufacturer will go to any length and expense to keep from losing/paying a lawsuit. This discourages future law suits.

She also said that just because a manufacturer says on their website that the device has a lifetime warranty doesn’t mean a thing unless you have something from that company in writing addressed to you with your name on the document. And just because you were given a card with the device and its serial number doesn’t mean that it came with a warranty. Lastly she said that your legal rights vary from state to state.

As far as recalls go, much of the time the device company will settle quietly to avoid a class action suit.