Recall Z-1099-2007 ยท GDW Staple, Implantable
Power Medical Interventions, Inc
Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60
| Date | Jul 24, 2007 (initiated May 12, 2007) |
| Status | Terminated |
| Reason | Malfunction - improper staple formation |
| Root cause | Other |
| Action | The field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites. |
| Quantity | 9 units |
| Distribution | The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052415 | POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS Power Medical Interventions, Inc., Sep 29, 2005 |