FDAFDA · Food and drugs·Recall number Z-2144-2012
Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.
Published August 15, 2012 · Recall initiated: July 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Distributor
- Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.
- Lot
- Lot Numbers: 950135R, 950136R, 950137R, 950138R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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