Reported Aug 15, 2012 · Terminated
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics…
Smith & Nephew, Inc. Endoscopy Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. Endoscopy Division · 150 Minuteman Drive · Andover, MA · 01810-1031
Is this the product you have?
- Smith & Nephew 5.5 mm Dyonics Bonecutter
- Electroblade Full Radius Part Number7205962
- Product UsageThe 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
- Lot codes and dates
- Lot Numbers
655844R950143R950144R950145R950146R
- Lot Numbers
- Amount recalled
- 108 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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