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