Synthes Recalls Every Fixation Nail System Sold Since 2004 |

Synthes Recalls Every Fixation Nail System Sold Since 2004

Synthes Recalls Every Fixation Nail System Sold Since 2004 (Orthopedics This Week)

Synthes Trauma has recalled every single Trauma Fixation Nail system sold in the U.S. since 2004. The company issued the voluntary recall on November 1.

During a validation test for a change to the company’s sterile packaging, it was discovered that the outer pouch, which holds a sterile, internal pouch, may have been compromised. The recall is not being undertaken on the basis of adverse events.

The company “strongly urges” customers to return the devices and replacement product will be provided once it becomes available. If however, returning the device adversely impacts a hospital’s ability to provide medical care, the hospital may choose to re-sterilize the product per company instructions.

Debbie Williams, DePuy Synthes Companies’ communications director, told OTW that a review of the company’s packaging process has identified improvements to the packaging process, which are now in place to prevent the issue from recurring. “We are already packaging and shipping nails with the new process and we are ready to re-process inventory that is being returned.”

Industry sources told us that competitors have ramped up production of their own fixation nails to take advantage of any gaps in the market.

Stan Mendenhall, editor and publisher of Orthopedic Network News told us that this was a big deal. He said most of the nails are used during hip fracture surgery. Mendenhall said Synthes’ share of cephalomed (the generic name) nails in 2011 was 31.6% of the market. With 347,000 hospitalized hip fractures every year, of which 64% are treated with the nails, it makes this one of Synthes’ top sellers.

Read the Synthes Recall Notice here.

5 responses to Synthes Recalls Every Fixation Nail System Sold Since 2004

  1. randall holcombe May 7th, 2018 at 1:50 am

    1n 204 they recall medical devices the fixation nails and 209 i had my first survey on my right hips the doctor use the fixation nails and in 2013 i had a 2 survey on my same hip because the fixation nails can’t lose and made a little hole in my right hips and my hips got infection and the doctor had to cut out 5inc of my bone because the infection kill some of my bone and in 2012 they recall the medical devices the fixation nails for the 2 time and because of this my hold live is mess up the companies knew this and my doctor had to know this but the company synthes knew this but the company did not send me a letter letting me know about this and my doctor did not let me know a thing about the recall of this medical devices fixation nails it been so that I can not find a lawyer but I am not going to give up until I find a lawyer and get justue people got to know about this fixation nails before more people are hurt by this medical devices fixation nails if I have to go to tv and put it on the news and go to the new paper and tell my story

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  2. randall holcombe May 28th, 2018 at 4:41 am

    they are still recall trochanteric fixation nails i got a real good case but I can’t find a lawyer to take my case I don’t think this is fair to me because of this my hold life is messed up and I am in a wheelchair for life if any lawyers are reading this i hope i find a lawyer to take my case

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  3. randall holcombe May 30th, 2018 at 7:07 am

    i am really mad because trochanteric fixation nails has been recall so many times and this company Johnson and Johnson did not send me a recall letter telling me about this recall and my doctor did not let me know a thing about this recall if someone let me know something about this recall sooner i could went back to my doctor and my doctor could fixed my hips but no body let me know a thing about this recall and my doctor had to take out the trochanteric fixation nails out of my right hips and I had so much infection my doctor had to cut out 5inc of my bone out of my hips and now I can’t walk and I can’t find a lawyer to take my case this has messed my hold life up

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  4. randall holcombe June 11th, 2018 at 5:25 am

    this company did not send me a recall letter if this company send me a recall i could have went back to my doctor and my doctor could done something to fixed my hips but seen this sorry companies did not send me a recall letter my hips got infection and my doctor had to take out the trochanteric fixation nails and I had so much infection in my hips the infection kill some of my bone in my hips my doctor had to cut out 5inc of my bone out of my hips if the infection got in to my blood it would have kill me but do you think this company care if I died are not no they don’t care has long has they make money and now my hold life is messed up and because of this company i can not walk there medical devices messenger my life up

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  5. Danny August 17th, 2018 at 1:51 pm

    My daughter had hip 3 hip surgery this year and twice she had Depuy Synthes and the nails broke or bend once and the plate broke the second time
    Now she has different type hardware
    Does anybody know any attorney in Florida who can help me out

        Reply

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