FDA Increases Severity of Cutting Guide Recall to Class I


Anonymous

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"Last fall Kalamazoo, Mich.-based Stryker voluntarily urged physicians to discontinue use of its ShapeMatch orthopedic product, but recently the FDA upgraded the recall to a Class 1, indicating probability of serious health consequences or death, according to Michigan Live.

The ShapeMatch Cutting Guides are designed to assist with total knee replacement positioning. Originally, they were recalled because construction may not have been in accordance with preoperative planning parameters and without 510(k) approval, according to the report."

http://www.beckersasc.com/asc-suppl...of-stryker-knee-device-recall-to-class-1.html
 
Just read about this on Stryker site but it did not say if this settled their issue with the FDA/DOJ from 2010. Was the DOJ issue closed out with this Class I Recall? Boy, this has been a mess for a long time now. Is this sales agony finally over?
 
Just read about this on Stryker site but it did not say if this settled their issue with the FDA/DOJ from 2010. Was the DOJ issue closed out with this Class I Recall? Boy, this has been a mess for a long time now. Is this sales agony finally over?

Why do you think this has anything to do with the DOJ ??
 
About a year ago I read something that there was an Otismed issue and Stryker was trying to settle it with the DOJ. Perhaps that was already put to bed and it never hit the press.
 
What is the ShapeMatch/OtisMed recall all about? I have not read anything about it recently. Is this somehow related to the DOJ action I read about back in 2010?


This is very simple. The shape match approach to aligning the knee may deliver improved short term outcomes there is some evidence to suggest this. However there is no evidence to support the long term survivorship and in fact the resulting alignment could be described as falling outside of the clinically proven alignment goals of TKR.

Ask the Depuy boys what can happen when you don't follow proven clinical approaches.
 
I agree with the above. Dr. Hozack and many other clinical experts warned all of us about taking the unproven clinical pathway. Too bad so many patients have had to suffer.
 
This is very simple. The shape match approach to aligning the knee may deliver improved short term outcomes there is some evidence to suggest this. However there is no evidence to support the long term survivorship and in fact the resulting alignment could be described as falling outside of the clinically proven alignment goals of TKR.
just to claify, Shapematch in the US is based on mechanical alignment. the original OtisMed was based on anatomic. This is still an option outside the US only. The FDA was clear about how they wanted it done. The reason for the recall was that there was an issue in the CT version of shapematch.
 
I agree with the above. Dr. Hozack and many other clinical experts warned all of us about taking the unproven clinical pathway. Too bad so many patients have had to suffer.

How many patients suffered? I need to see this data.
Is it more than the 93,000 implanted ASRs with an estimated 30%+ failure rate?
 
Is this really Stryker's defense? We didn't mess up as bad as ASR so it's not a big deal. ASR has nothing to do with Rejuvenate and Shapematch recalls. Time to man up boys and own it.
 
just to claify, Shapematch in the US is based on mechanical alignment. the original OtisMed was based on anatomic. This is still an option outside the US only. The FDA was clear about how they wanted it done. The reason for the recall was that there was an issue in the CT version of shapematch.

what's wrong with CT imaging? other than it doesn't pick up cartilage? Materialise still processes CT's.
 
what's wrong with CT imaging? other than it doesn't pick up cartilage? Materialise still processes CT's.

Nothing. It was a software issue in the ct process, not MRI.
 
OtisMed/Shapematch has been a problem since 2006. This technology has been a big waste of money and it still keeps sucking funds from legit. product developments. Whoever made the call to buy this garbage really blew it.
 
I agree with the above. Dr. Hozack and many other clinical experts warned all of us about taking the unproven clinical pathway. Too bad so many patients have had to suffer.

If you agree with Hozack then you like to contradict yourself. He had a 4 patient paper published that was COMPLETE garbage and never should have been published then to write up a paper showing if I remember correctly 95% accuracy with the guides. He like ALL the stryker consultants are pathetic excuses of "thought leaders" in ortho.
 
All of Stryker consultants are stupid? What does that say about the Company, past and current, management? Are poor quality consultants responsible for the 2% sales growth or is it the poor quality AVP and upper management? How many times in the last 6 years has O'Brien hit the Salesforce sale quota? Not the lower quota he gets from corporate. The one he raises for the salesforce. Two sets of quota books , what a leader.
 
OtisMed/Shapematch has been a problem since 2006. This technology has been a big waste of money and it still keeps sucking funds from legit. product developments. Whoever made the call to buy this garbage really blew it.

This is all that needs to be said. Stryker took the easy route by trying to buy a product instead of create it in house. It has been a major backfire. Time will tell if this will in fact be the next standard of care. Don't forget they said that about navigation about 6-7 yrs ago.

Btw, we can thank S&N for eroding price right out of the gate. Someone please buy that shit company already!
 


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