The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Robert Justin Marcus - JPMorgan Chase & Co, Research Division - Analyst
: Adam, a couple of questions, if I can. A lot of us had been hearing you talk really against the possibility of a recall for several months now since the
issue with XTRA FLEX first came out. So one, is this -- it's clearly again a recall, but do you view this as a tone change? A lot of people are concerned
that it might really be an issue with trust management. Just try and help us understand what -- how it evolved over the past few months. How
much of this is different from what you said previously? And then I have a question after that.
Question: Robert Justin Marcus - JPMorgan Chase & Co, Research Division - Analyst
: Got it. Two other quick ones for me. You gave the stat recently that XTRA FLEX was 7.5% of sales in third quarter. What have you been seeing, let's
say, the past month or so? Has the number gone up or down as people have adjusted to the issues? And if you could give us sort of -- you gave us
the financial impact, which seems much more of recalling inventory, but how you think this might affect just sales on a go-forward basis, and then
I'll ask my last question. There's a lot of concern that people are seeing increased rates of -- in the MAUDE database of Lightning 12. Just if you
could give us a statement on Lightning 12. And do you see any of these issues potentially moving into other products?
Question: William John Plovanic - Canaccord Genuity Corp., Research Division - Analyst
: Great. Just trying to understand as you go through, what was the new information that you received to drive the recall decision? Because you're
having discussions with the FDA and something else. Kind of -- I mean, that discussion was ongoing. And then have you made any staffing or
process changes associated with this JET 7 testing recall?
And then I'd just add on international. We haven't really talked about it, but I don't think XTRA FLEX was really being sold international. So I don't
think that impacts the international business, but just a confirmation on that.
Question: William John Plovanic - Canaccord Genuity Corp., Research Division - Analyst
: Sorry. We always talk fast. What new information did you receive to drive that recall decision?
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DECEMBER 15, 2020 / 10:30PM, PEN.N - Penumbra Inc Investor Update
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