Class 2 Device Recall Stableloc (TM) External Fixation System

• Date Initiated by Firm: July 09, 2008
• Date Posted: March 16, 2010
• Recall Status: Terminated on May 21, 2010
• Recall Number: Z-1154-2010
• Recall Event ID: 48976
• 510(K)Number: K965029
• Product Classification: Invasive Traction Component - Product Code JEC
• Product: Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE"
• Code Information: Part number (REF): FX-4001-S; Lot numbers (Work order #): W53416, W53682, W53683, and W53684.
• Recalling Firm/ Manufacturer: Acumed LLC; 5885 NW Cornelius Pass Rd; Hillsboro OR 97124-9370
• For Additional Information Contact: Richard F. Snyder; 503-627-9957 Ext. 1302
• Manufacturer Reason for Recall: Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw.
• FDA Determined Cause: Process control
• Action: The firm sent "Urgent Field Safety Notice: Medical Device Recall" letters to customers 7/9-11/08. In addition, the firm sent the letter via e-mail to some of the customers. The notification advised the customer of the recall, identified the product, explained the reason, and asked the customer to locate and segregate any affected product. The customer was asked to notify their customers who they had distributed the affected product to and asked them to complete and return an enclosed response form. The firm provided a model recall letter for its agents/distributors to issue to users. Upon receipt of the response form, the firm will contact customers to arrange for replacement of any affected product. Questions should be directed to the "Distributor phone number" or Richard Snyder, Quality Manager at 1-888-627-9957.
• Quantity in Commerce: 80 kits
• Distribution: Worldwide Distribution -- USA, including states of VA, NC, FL, ME, WA, GA, TX and PA and countries of Spain, Japan and Greece.
• 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 = JEC