Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101, Rx only, Smith & Nephew, 1450 Br
FDA device recall Z-1695-2009 · posted 2009-08-04 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Problems with transducer may result in a reduced ultrasound output.
- Action taken
- 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
- Status
- Terminated
- Product code
- LPQ
- Quantity affected
- 4139 units
- Distribution
- Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.
- Date initiated
- 2009-06-05
- Date posted
- 2009-08-04
- Date terminated
- 2010-11-18
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.