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Smith & Nephew: RENASYS RECALL PR Spin UnSpun

Smith & Nephew: RENASYS RECALL PR Spin UnSpun

June 23, 2014

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Today Smith & Nephew issued a press release:

…announces that it has temporarily ceased commercial distribution of the RENASYS Negative Pressure Wound Therapy product line in the United States.

This action follows instruction from the FDA to obtain new regulatory clearances through the premarket notification (510K) process in respect of certain design enhancements made to RENASYS systems. The applications for clearance have now been filed and are awaiting action.

This action only affects RENASYS products in the United States. OtherNPWT products, including PICO, Smith & Nephew’s portable, canister-free system, are not affected.

Smith & Nephew is working cooperatively with the FDA to address its concerns in order to resume distribution of RENASYS products in the United States as soon as possible and regrets any disruption caused to customers.

Sales of RENASYS products in the United States accounted for less than 5% of global Advanced Wound Management revenue in 2013.

Unlike many companies that use language like “they decided” Smith & Nephew did not have that option since the instructions are coming directly from the FDA.  (That’s a big red flag).  How hard is it for device companies to fill out the 510(k)s  properly?  Apparently it’s a growing trend.   At least the FDA is FINALLY catching on but they still need to catch up!

Language we have seen before:  “less than 5%” is meant to downplay the product and is often used to deflect from something bigger. So let’s keep the characteritics in mind as this story unfolds:

Checklist of Characteristic of The Sociopathic Business Model

Here is a link to an anonymous message board known as Medtechy as it relates to the Renasys recall.  These boards can often be salty but there is usually an element of truth and a very distinct pattern.  Reps are concerned, management denies, demeans and insults, then threats are made against the concerned reps.  Under this model executives and management do not like to be challenged even if what they are doing is unethical or illegal.  We don’t know that to be case here, but we’ll have to let it unfold more and follow the PR around Renasys.

And MAUDE reports on this product are missing according to the Medtechy Smith & Nephew thread.  Interesting.

 

2 Comments
  • Pastor Jim
    Reply

    Holeeeeey Carp! Every time I think I’ve had all the naivete sandpapered off my poor raw soul, something like that Medtechy board will show up and prove me wrong.

    I can see now a bit more of why you had to get out of that business…why anyone with an iota of moral fiber would be stung by the attitudes of some of their “colleagues.” Sounds like a bunch of hard-nosed user car jocks out back on the lot doing a doob and discussing how to foist their clunkers off on the rubes!

    June 25, 2014 at 4:35 am

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