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.
FDA Recall Z-1602-2010 · Posted 2010-05-14
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Recalling FirmAcumed LLC
Recall StatusTerminated
Product CodeHWC
Date Initiated2009-05-19
Date Terminated2010-05-17
Product Quantity83
Reason for Recall
Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw
Firm 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.
Root Cause
Employee error
Distribution Pattern
Worldwide distribution: USA including FL, GA, MI, MN, NY, TX, VA and countries of United Kingdom, Herzeles, South Korea, South Africa, China, and Milan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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