—#64587

Product

Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972266, SIZE 6 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA

FDA product code: MJO — Prosthesis, Intervertebral Disc
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P060018
Affected lot / code info: Lot Numbers: CN07A030, CN07A024, 434226, 505039, 515349, 514674, 515343, 520034, 515347, 517759, 520032, 520033, 513711, 515350 and 508115

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2007-09-04
Posted by FDA: 2007-12-19
Terminated: 2008-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64587. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.