Recall Z-0143-2008 ยท MJO Prosthesis, Intervertebral Disc
Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972287, SIZE 7 X 18, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
| Date | Dec 19, 2007 (initiated Sep 4, 2007) |
| Status | Terminated |
| Reason | Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated. |
| Root cause | Device Design |
| 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 | 196 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.