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U.S. Department of Health and Human Services

Class 2 Device Recall Intramedullary Fixation Rod

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  Class 2 Device Recall Intramedullary Fixation Rod see related information
Date Initiated by Firm August 21, 2008
Date Posted May 10, 2010
Recall Status1 Terminated 3 on May 14, 2010
Recall Number Z-1552-2010
Recall Event ID 49383
510(K)Number K031438  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
Code Information 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.
Recalling Firm/
Manufacturer		 Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9370
For Additional Information Contact Richard Snyder
503-627-9957 Ext. 293
Manufacturer Reason
for Recall		 Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = ACUMED LLC
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