Date Initiated by Firm |
May 12, 2007 |
Date Posted |
July 24, 2007 |
Recall Status1 |
Terminated 3 on August 29, 2007 |
Recall Number |
Z-1099-2007 |
Recall Event ID |
37982 |
510(K)Number |
K052415
|
Product Classification |
surgical staple - Product Code GDW
|
Product |
Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60 |
Code Information |
Model number PLC60. Serial numbers: DO6E0133, DO6E253, DO6E173, DO6E233, DO6E223, DO6E383, DO6G0093, DO6E0043, and DO6E0013. |
Recalling Firm/ Manufacturer |
Power Medical Interventions, Inc 2021 Cabot Blvd W Langhorne PA 19047-1810
|
For Additional Information Contact |
Barbara Whitman 267-775-8100
|
Manufacturer Reason for Recall |
Malfunction - improper staple formation
|
FDA Determined Cause 2 |
Other |
Action |
The field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites. |
Quantity in Commerce |
9 units |
Distribution |
The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GDW and Original Applicant = POWER MEDICAL INTERVENTIONS, INC.
|