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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 Device Recall Power Linear Cutter Reusable Digital Loading Units with Reloadssee related information
Date Initiated by FirmMay 12, 2007
Date PostedJuly 24, 2007
Recall Status1 Terminated 3 on August 29, 2007
Recall NumberZ-1099-2007
Recall Event ID 37982
510(K)NumberK052415 
Product Classification surgical staple - Product Code GDW
ProductPower 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 ContactBarbara Whitman
267-775-8100
Manufacturer Reason
for Recall
Malfunction - improper staple formation
FDA Determined
Cause 2
Other
ActionThe field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites.
Quantity in Commerce9 units
DistributionThe products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GDW
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