Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
FDA Recall Z-1552-2010 · Posted 2010-05-10
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Recalling FirmAcumed LLC
Recall StatusTerminated
Product CodeHSB
Date Initiated2008-08-21
Date Terminated2010-05-14
Product Quantity36 devices
Reason for Recall
Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to 6 consignees, 1 consignee located each in MA, CA, NM, TX, and the United Kingdom and South Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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