Class 2 Device Recall cortical bone screw

• Date Initiated by Firm: May 19, 2009
• Date Posted: May 14, 2010
• Recall Status: Terminated 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: 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