Class 2 Device Recall Straight Linear Cutter

• Date Initiated by Firm: September 23, 2009
• Date Posted: November 23, 2009
• Recall Status: Terminated on March 08, 2010
• Recall Number: Z-0396-2010
• Recall Event ID: 53694
• 510(K)Number: K020719
• Product Classification: Implantable staple. - Product Code GDW
• Product: Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, product code SLCR55B; Straight Linear Cutter 55 mm Green Reload, product code SLCR55G; Straight Linear 4 Row No Knife Digital Loading Unit, product code SLS55B4.
• Code Information: all codes
• Recalling Firm/ Manufacturer: Surgical Devices/Covidien; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: Customer Service; 866-769-3763
• Manufacturer Reason for Recall: Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.
• Quantity in Commerce: 78,579 units
• Distribution: The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece.
• 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