M/DN Intramedullary Fixation Humeral Nail
FDA device recall Z-1004-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.
- Action taken
- Units were distributed to twelve (12) consignees in the US and seven (7) foreign consignees (China, Japan, Korea, El Salvador, Singapore, Taiwan and UK)
- Root cause
- Other
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 33 units
- Date initiated
- 2004-03-16
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-02
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAMEDULLARY NAIL SYSTEM (K965098) | Zimmer, Inc. | 1997-02-28 |