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U.S. Department of Health and Human Services

Class 2 Device Recall Exogen 4000Ultrasound Bone Healing System

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 Class 2 Device Recall Exogen 4000Ultrasound Bone Healing System see related information
Date Posted August 04, 2009
Recall Status1 Terminated on November 18, 2010
Recall Number Z-1695-2009
Recall Event ID 52228
PMA Number P900009 
Product Classification Exogen 4000+ Ultrasound Bone Healing System - Product Code LPQ
Product Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116.

The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.
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Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
901-396-2121 Ext. 5373
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall
Problems with transducer may result in a reduced ultrasound output.
FDA Determined
Cause 2
Other
Action All affected Smith & Nephew consignees and distributors were notified of problem and the recall by letters (dated June 5, 2009 and June 8, 2009) via US mail. Patients were directed to return the instruments; physicians were informed that their patients were being contacted; and distributors were requested to return their stock and to notify anyone to whom the product was distributed to also return the product. Direct questions to Smith & Nephew, Inc. by calling at 1-800-836-4080.
Quantity in Commerce 4139 units
Distribution Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.
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.
PMA Database PMAs with Product Code = LPQ and Original Applicant = BIOVENTUS LLC
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