Acumed LLC Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
Brand
Acumed LLC
Lot Codes / Batch Numbers
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.
Products Sold
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.
Acumed LLC is recalling Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distribu due to Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, MA, NM, TX
Page updated: Jan 10, 2026