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U.S. Department of Health and Human Services

Class 2 Device Recall Power Linear Cutter Reusable Digital Loading Units with Reloads

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 Class 2 Recall
Power Linear Cutter Reusable Digital Loading Units with Reloads
see related information
Date Posted July 24, 2007
Recall Status1 Terminated on August 29, 2007
Recall Number Z-1099-2007
Recall Event ID 37982
Premarket Notification
510(K) Number
K052415 
Product Classification Staple, Implantable - 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, Pennsylvania 19047-1810
For Additional Information Contact Barbara Whitman
267-775-8100
Manufacturer Reason
for Recall
Malfunction - improper staple formation
FDA Determined
Cause 2
DESIGN: Device Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = POWER MEDICAL INTERVENTIONS, INC.
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