03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 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. [Code Info] Lot Numbers: 655844R, 950143R, 950144R, 950145R, 950146R [Reason for Recall] Device 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. [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification] 
Class II
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Enforcement Report - Week of August 15, 2012