| Date Initiated by Firm | March 16, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on July 02, 2004 |
| Recall Number | Z-1004-04 |
|---|
| Recall Event ID |
28623 |
| 510(K)Number | K965098 |
|---|
| Product Classification |
Rod, Fixation, Intramedullary And Accessories - Product Code HSB
|
| Product | M/DN Intramedullary Fixation Humeral Nail |
|---|
| Code Information |
Catalog no. 00-2254-195-09 Lot # 20118000 |
Recalling Firm/
Manufacturer |
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
|
| For Additional Information Contact | Connie Morgan
574-372-4269 |
|---|
Manufacturer Reason
for Recall | One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 33 units |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = HSB
|
|---|
