Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.
FDA device recall Z-0463-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.
- Action taken
- Smith & Nephew Inc. Endoscopy Division notified facilities on 11/7/11 via an "Urgent - Product Recall 1st Notification - Urgent" letter and/or phone. The letter identified the affected product and the reason for the recall. It also discussed the potential risks, customer actions, and instructions for the return of the product. Customers were to check their inventory and locate any of the affected product. They were to also complete the requested contact information and return the notification letter. In addition, customers were to contact Smith & Nephew Endoscopy Division Returns Group at endo.andreturns@smith-nephew.com for information on how to return the affected product and receive replacement product. Questions, contact Hoangthi Le directly by phone at 508-337-3731.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 1743 units
- Distribution
- Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Dubai, Finland, France, Germany, Norway, South Africa, Switzerland, United Kingdom, and Venezuela.
- Date initiated
- 2011-11-07
- Date posted
- 2012-01-11
- Date terminated
- 2016-02-22
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DYONICS ELECTROBLADE RESECTOR (K012314) | Smith & Nephew, Inc. | 2002-02-01 |