The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractu
FDA device recall Z-1357-2012 · posted 2012-04-02 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates.
- Action taken
- Acumed sent an Urgent Notice Device Recall letter dated March 5, 2012, to all affected consignees. A follow-up notification letter was sent to the domestic customers on March 9, 2012. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were instructed to further notify their consignees about the recall and to cease use of and return the affected product. Consignees were requested to respond using the enclosed response form. The form should be faxed to 503-520-9618. For questions regarding this recall call 503-627-9957, ext. 1302.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 12 rods
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Italy, Ireland, and Great Britain.
- Date initiated
- 2012-03-07
- Date posted
- 2012-04-02
- Date terminated
- 2012-07-25
- Location
- Hillsboro, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAMEDULARY FIXATION ROD (K951740) | Acu Med, Inc. | 1995-08-11 |