Recall Z-1357-2012 ยท HSB Rod, Fixation, Intramedullary And Accessories
Acumed LLC
The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus Humeral Fixation System Size: 8mm X 240mm Polarus Plus Humeral Rod***Titanium***REF HR-0824-S***LOT 266220***RX only***Manufactured or distributed by: ACUMED 5885 NW Cornelius P
| Date | Apr 2, 2012 (initiated Mar 7, 2012) |
| Status | Terminated |
| Reason | The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 12 rods |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Italy, Ireland, and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951740 | INTRAMEDULARY FIXATION ROD Acu Med, Inc., Aug 11, 1995 |