Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
This recall has been terminated (originally issued May 10, 2010).
- Company
- Acumed Llc
- Recall Initiated
- August 21, 2008
- Posted
- May 10, 2010
- Terminated
- May 14, 2010
- Recall Number
- Z-1552-2010
- Quantity
- 36 devices
- Firm Location
- Hillsboro, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.
Distribution
Product was distributed to 6 consignees, 1 consignee located each in MA, CA, NM, TX, and the United Kingdom and South Africa.
Lot / Code Info
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.
Root Cause
Other
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.