More info on Prestige Recall

[sahuaro]

Is this for all Prestige ST's or just those lot numbers, i.e., do those lot numbers comprise the entire universe of Prestige ST's?

[B13s]

Originally Posted by sahuaro

Is this for all Prestige ST's or just those lot numbers, i.e., do those lot numbers comprise the entire universe of Prestige ST's?

You can look for more info on FDA website - looks like other lots are affected as well: http://www.accessdata.fda.gov/script...event_id=44953

[mmglobal]

Making an educated guess here, so take it with a grain of salt. It looks like the issue with the trial implant sizing, not a manufacturing error in some lots of discs. Since they don't know what size they'll use, even if some of the trials are OK, I would think that they need to get the problems resolved before moving forward.

Mark

[sahuaro]

I just spoke with Bert Kelly at Medtronic--the name and number listed on the FDA recall page as the contact person. The recall has to do with the sizing guide. He said that they were having different results depending on the size of the patient with the sizing guide so it has been redesigned to be consistent independent of patient size. He indicated that the recall was made in September and all the sizing guides involved were returned by October, so there are no recalled parts in the field. He also indicated that over 1000 Prestige ST's had been implanted since the summer (i.e., FDA approval). Whew!