Recall Z-0716-04 ยท HTO Reamer
Apex Surgical, LLC
Apex Pilot Shaft 14.4mm
| Date | Jul 20, 2004 (initiated Jan 17, 2003) |
| Status | Terminated |
| Reason | Pilot shaft may break during reaming or broaching of the femur |
| Root cause | Other |
| Action | Apex Surgical notified accounts by letter on 1/17/03, advising users to discontinue use of the stem pilots and return the pilots, and associated broaches and reamers because they would not be interchangeable with the new design. |
| Quantity | 45 units |
| Distribution | CT, OH, FL, OK, TX, RI, NV, SC, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.