More info on Prestige Recall

[mmglobal]

There has been some discussion in the past about a recall of the Prestige cervical disc. Starting in September, some surgeries were cancelled as access to the discs was denied.

Yesterday, the FDA website finally has some info on it:

Date Recall Initiated: September 04, 2007

Date Posted: December 19, 2007

Recall Number: Z-0138-2008

Product: Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA

Code Information Lot Numbers: CN07G002, CN07F006, 434150, CN06M009, CN6M016, and 506850

Recalling Firm / Manufacturer:
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis , Tennessee 38132-1719

For Addition Information Contact Bert Kelly
901-396-3133

Reason For Recall: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

Action: The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection.

Quantity in Commerce 196 units

Distribution Nationwide

[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!