Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: T
FDA device recall Z-2144-2012 · posted 2012-08-03 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- 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.
- Action taken
- Smith & Nephew sent an Urgent - Product Recall 1st Notification Letter dated July 2012 via Federal Express to all affected customers. The letter identified the affected product, potential risk and actions to be taken. Customers were instructed to examine inventory, quarantine immediately, complete the form attached indicating the lot numbers and quantities. The letter also instructed customers to contact Smith & Nephew Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. They will provide customers with instructions for returning affected products and receiving a credit. Each OUS affiliate shall be notified via (email or equivalent) of the recall by Smith & Nephew Inc.; the affiliate must then notify each facility affected by the recall. For question concerning this recall call 405-917-8585 or 978-749-1630.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 340 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.
- Date initiated
- 2012-07-14
- Date posted
- 2012-08-03
- Date terminated
- 2021-03-22
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DYONICS ELECTROBLADE RESECTOR (K012314) | Smith & Nephew, Inc. | 2002-02-01 |