CHECK THIS OUT!!! This is from Today's WallStreet Journal.
Click on link:
Cochlear Identifies cause of Failure
Dec. 20, 2011, 2:02 a.m. EST
Cochlear identifies cause of implant failures
Sponsored: TheStreet Raymond James' Best Stock Picks May Double in 2012
Cochlear identifies cause of implant failures that led to recall
-- Understanding forms basis for plan to return Nucleus CI500 series to market
-- 1.9% of series devices have failed
(Adds share closing price in third paragraph, CFO comments in fifth and sixth paragraphs, background in fourth and seventh paragraphs)
MELBOURNE (MarketWatch) -- Cochlear Ltd. said Tuesday hearing implant failures that led to the voluntary recall of its un implanted Nucleus CI500 series were caused by microcracks in a joint that let water into the device.
"This understanding of the root cause now forms the basis of the plan for the return of the Nucleus CI500 series implant to market," Chief Executive Chris Roberts said in a letter to clinicians filed with the Australian Securities Exchange.
Shares in Cochlear, the world's biggest maker of bionic ears, leapt on the news, closing up 16%.
Cochlear recalled its Nucleus CI500 range, which Cochlear says is the world's slimmest titanium hearing implant, in September after an unexplained number of failures.
Chief Financial Officer Neville Mitchell told Dow Jones Newswires there was no time line "at this stage" for the return of the device to the market.
"What we'll need to do is look at the design and then test that design again and then put it through regulatory approvals and market it after that," he said.
Cochlear has made a provision of A$130 million-A$150 million to cover the cost of the recall.
Roberts said in the letter about 1.9% of registered CI500 series devices had failed, but there were fewer reported failures in November 2011 than in October 2011. There are about 30,000 registered CI500 series devices around the world.
He said the company's investigation into the failures pointed to unexpected variations in the manufacturing process resulting in a limited number of implants being more susceptible to developing microcracks.
"These microcracks allow water molecules to enter the implant resulting in the malfunction of specific electronic components," Roberts said.
Update on the Nucleus 5 this is from Nov 11, 2011
and this last letter is from Cochlear sent to all the Clinics...
Letter From Cochlear