Recall Z-1552-2010 ยท HSB Rod, Fixation, Intramedullary And Accessories
Acumed LLC
Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
| Date | May 10, 2010 (initiated Aug 21, 2008) |
| Status | Terminated |
| Reason | Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material. |
| Root cause | Other |
| Action | On 8/21/2008 the firm initiated telephone contact with consignees, followed by an e-mail, and a letter. Consignees were instructed to return product to the firm. Consignees were provided with a response form to complete and return to the firm. For additional information, please contact the firm directly at telephone 888-627-9957. |
| Quantity | 36 devices |
| Distribution | Product was distributed to 6 consignees, 1 consignee located each in MA, CA, NM, TX, and the United Kingdom and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031438 | ACUMED SMALL BONE LOCKING ROD SYSTEM II Acumed, LLC, Jul 17, 2003 |