Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60
FDA device recall Z-1099-2007 · posted 2007-07-24 · Terminated
Recall details
- Recalling firm
- Power Medical Interventions, Inc
- Reason for recall
- Malfunction - improper staple formation
- Action taken
- The field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites.
- Root cause
- Other
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 9 units
- Distribution
- The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany
- Date initiated
- 2007-05-12
- Date posted
- 2007-07-24
- Date terminated
- 2007-08-29
- Location
- Langhorne, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS (K052415) | Power Medical Interventions, Inc. | 2005-09-29 |