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U.S. Department of Health and Human Services

Class 2 Device Recall cortical bone screw

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  Class 2 Device Recall cortical bone screw see related information
Date Initiated by Firm May 19, 2009
Date Posted May 14, 2010
Recall Status1 Terminated 3 on May 17, 2010
Recall Number Z-1602-2010
Recall Event ID 55184
510(K)Number K942340  
Product Classification Screw, fixation, bone - Product Code HWC
Product Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR

Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal.
Code Information Lot code 203214
Recalling Firm/
Manufacturer		 Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9432
For Additional Information Contact
503-627-9957 Ext. 293
Manufacturer Reason
for Recall		 Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw
FDA Determined
Cause 2		 Employee error
Action On May 18, 2009, the firm, ACUMED, began calling customers. On May 19, 2009, the ACUMED sent e-mails and a "URGENT NOTICE: DEVICE RECALL" Initial Notice letter to all customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to identify the product having the lot code(s) and quarantine them, return all products from the lot code(s) to Acumed immediately, to please notify the customers of this recall if you further distributed this product, and complete and return the Acumed Product Recall Effectiveness Form. Please contact Acumed Customer Service at 1-888-627-9957 for any questions regarding this notification.
Quantity in Commerce 83
Distribution Worldwide distribution: USA including FL, GA, MI, MN, NY, TX, VA and countries of United Kingdom, Herzeles, South Korea, South Africa, China, and Milan
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 = HWC and Original Applicant = ACUMED, INC.
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