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.
FDA Recall Z-1695-2009 · Posted 2009-08-04
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Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeLPQ
Date Initiated2009-06-05
Date Terminated2010-11-18
Product Quantity4139 units
Reason for Recall
Problems with transducer may result in a reduced ultrasound output.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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