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

• Date Initiated by Firm: May 12, 2007
• Date Posted: July 24, 2007
• Recall Status: Terminated 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: 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