Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60
This recall has been terminated (originally issued July 24, 2007).
- Company
- Power Medical Interventions, Inc
- Recall Initiated
- May 12, 2007
- Posted
- July 24, 2007
- Terminated
- August 29, 2007
- Recall Number
- Z-1099-2007
- Quantity
- 9 units
- Firm Location
- Langhorne, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Malfunction - improper staple formation
Distribution
The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany
Lot / Code Info
Model number PLC60. Serial numbers: DO6E0133, DO6E253, DO6E173, DO6E233, DO6E223, DO6E383, DO6G0093, DO6E0043, and DO6E0013.
Root Cause
Other
Action Taken
The field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites.