SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)
This recall has been terminated (originally issued July 24, 2003).
- Company
- Power Medical Interventions
- Recall Initiated
- June 30, 2003
- Posted
- July 24, 2003
- Terminated
- March 16, 2004
- Recall Number
- Z-1048-03
- Quantity
- 4211 units
- Firm Location
- New Hope, PA
- Official Source
- View on FDA website ↗
Reason for Recall
latching mechanism failure
Distribution
The products were shipped to medical facilities and sales representatives nationwide. The products were also shipped to distributors in Belgium, Germany, Ireland, Israel, Italy, Japan, Netherlands, and Spain
Lot / Code Info
Lot numbers DS-000036, DS-000043, DS-000047, DS-000049, DS-000052, DS-000055, DS-000057, DS-000061, DS-000064, DS-000072, DS-000073, DS-000077, DS-000078, DS-000082, DS-000084, DS-000085, DS-000086, DS-000090, DS-000095, DS-000099, DS-000117, DS-000118, DS-000119, DS-000126, DS-000132, DS-000133, DS-000135, DS-000138, DS-000140, DS-000141, DS-000145, LC-000022, LC-000023, LC-000024, LC-000030, LC-000044, LC-000052, LC-000053, LC-000055, LC-000056, LC-000061, LC-000066, LC-000068, and LC-000074.
Root Cause
Other
Action Taken
The recalling firm issued a recall letter dated 6/30/03 to their accounts informing them of the recall and the need to return the product.