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U.S. Department of Health and Human Services

Class 2 Device Recall Ankle Traction Boot

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 Class 2 Recall
Ankle Traction Boot
see related information
Date Posted March 18, 2013
Recall Status1 Terminated on August 07, 2013
Recall Number Z-0959-2013
Recall Event ID 64509
Product Classification Apparatus, Traction, Non-Powered - Product Code HST
Product Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.
Code Information A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322
Recalling Firm/
Manufacturer
Allen Medical Systems, Inc.
One Post Office Square
Acton, Massachusetts 01720
For Additional Information Contact Nancy Royalty
978-263-5401 Ext. 4280
Manufacturer Reason
for Recall
Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Allen Medical Systems sent a "Urgent Medical Device Recall" letter dated February 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken. Customers were instructed to: 1. Immediately remove from service your Allen Traction Boot with the serial number(s) XXXXX 2. Contact Allen Medical Customer Service at (800) 433-5774 for an RMA number and instructions to return your Allen Traction Boot for inspection and repair if necessary. There will be no cost to you. 3. Return your Allen Traction Boot to Allen Medical as soon as possible. In order to minimize the inconvenience, we will repair your Allen Traction Boot and return the device to you within 48 hours of receipt.
Quantity in Commerce 24 devices
Distribution Worldwide Distribution- USA including the states of TX, NV, KY, GA, OH, PA, NY, AL, WA, IL and the countries of New Zealand and Japan.
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.
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