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U.S. Department of Health and Human Services

Class 2 Device Recall Stableloc (TM) External Fixation System

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 Class 2 Recall
Stableloc (TM) External Fixation System
see related information
Date Posted March 16, 2010
Recall Status1 Terminated on May 21, 2010
Recall Number Z-1154-2010
Recall Event ID 48976
Premarket Notification
510(K) Number
K965029 
Product Classification Component, Traction, Invasive - 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, Oregon 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 2
PRODUCTION CONTROLS: 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 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 = JEC and Original Applicant = ACUMED, INC.
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