Recall Z-1004-04 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Inc.
M/DN Intramedullary Fixation Humeral Nail
| Date | Jul 20, 2004 (initiated Mar 16, 2004) |
| Status | Terminated |
| Reason | One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation. |
| Root cause | Other |
| Action | Units were distributed to twelve (12) consignees in the US and seven (7) foreign consignees (China, Japan, Korea, El Salvador, Singapore, Taiwan and UK) |
| Quantity | 33 units |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965098 | INTRAMEDULLARY NAIL SYSTEM Zimmer, Inc., Feb 28, 1997 |