Class 2 Device Recall Fastlok Staple Impactor (8 mm size, 2023010)

• Date Initiated by Firm: May 17, 2006
• Date Posted: September 13, 2006
• Recall Status: Terminated on September 14, 2012
• Recall Number: Z-1501-06
• Recall Event ID: 35828
• Product Classification: ligament staple impactor - Product Code HXJ
• Product: Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010
• Code Information: N/A
• Recalling Firm/ Manufacturer: Xiros Plc; 28-30 Blenheim Terrace .; Leeds United Kingdom
• Manufacturer Reason for Recall: The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
• FDA Determined Cause: Other
• Action: Customer recall notifications included: a) Telephone notification to highest volume users b) Recall letters were sent via certified mail to all customers June 1, 2006. Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible.
• Quantity in Commerce: 10, none distributed in US
• Distribution: Nationwide & Worldwide, including Spain, Japan, UAE, Italy, 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.