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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 Recall
cortical bone screw
see related information
Date Posted May 14, 2010
Recall Status1 Terminated on May 17, 2010
Recall Number Z-1602-2010
Recall Event ID 55184
Premarket Notification
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, Oregon 97124-9432
Manufacturer Reason
for Recall
Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw
FDA Determined
Cause 2
TRAINING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ACUMED, INC.
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