Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible Part Number: 7205961
FDA device recall Z-1230-06 · posted 2006-07-13 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
- Action taken
- Smith & Nephew notified consignees by Certified letter dated 6/19/06. Accounts are requested to return product. Smith & Nephew expanded the recall on 8/2/5/06 by letter to include addtional lot numbers.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 445 boxes/Expanded 348 units
- Distribution
- Nationwide Foreign: Smith & Nephew Canada, Germany, France, Istanbul
- Date initiated
- 2006-06-19
- Date posted
- 2006-07-13
- Date terminated
- 2008-01-10
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR (K031675) | Smith & Nephew, Inc. | 2003-06-20 |