Recall Z-0050-2007 ยท HTO Reamer
Medtronic Sofamor Danek Instrument Manufacturing
Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic).
| Date | Oct 19, 2006 (initiated Aug 1, 2006) |
| Status | Terminated |
| Reason | Bone reamer may not have a cutting surface on the tip. |
| Root cause | Other |
| Action | The firm notified its hospital consignees by letter dated 08/01/2006. The letter requested cessation of use and return. |
| Quantity | 9 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.