Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsb
FDA device recall Z-1552-2010 · posted 2010-05-10 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 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.
- Date initiated
- 2008-08-21
- Date posted
- 2010-05-10
- Date terminated
- 2010-05-14
- 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 |
|---|---|---|
| ACUMED SMALL BONE LOCKING ROD SYSTEM II (K031438) | Acumed, LLC | 2003-07-17 |