Z-1552-2010

Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by...

Name: Z-1552-2010 Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by...
Creator: Acumed LLC
Published: 2008-08-21
License: https://open.fda.gov/license/

Acumed LLC / initiated 2008-08-21 / Terminated

FDA source

Acumed LLC began a recall of Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR on 2008-08-21. The reason FDA records is "Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1552-2010
Status: Terminated
Initiated: 2008-08-21
Posted: 2010-05-10
Terminated: 2010-05-14
Recalling firm: Acumed LLC
Product: Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.
FDA 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 in commerce: 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.
Product codes and lots: Model # 40-0028-S on lot # W65318, exp: 06/2015; Model # 40-0029-S on lot # W64072, exp: 06/2015; and Model # 40-0031-S on lot # W65319 exp: 06/2015.

Product code HSB

K031438Class IIAcumed Small Bone Locking Rod System IIAcumed, LLC / cleared 2003-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)