Smith & Nephew: RENASYS RECALL PR Spin UnSpun
June 23, 2014
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:
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.