Class 2 Device Recall

• Date Initiated by Firm: January 17, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on April 01, 2004
• Recall Number: Z-0713-04
• Recall Event ID: 26157
• Product Classification: Reamer - Product Code HTO
• Product: Apex Pilot Shaft, 10mm
• Code Information: Catalog Number: 690110 Lot Numbers: 128, 214
• FEI Number: 3002757749
• Recalling Firm/ Manufacturer: Apex Surgical, LLC; 12 Harding Street, Suite 202; Lakeville MA 02347
• For Additional Information Contact: Edward J. Cheal, Ph.D; 508-947-6500
• Manufacturer Reason for Recall: Pilot shaft may break during reaming or broaching of the femur
• FDA Determined Cause: Other
• Action: Apex Surgical notified accounts by letter on 1/17/03, advising users to discontinue use of the stem pilots and return the pilots, and associated broaches and reamers because they would not be interchangeable with the new design.
• Quantity in Commerce: 52 units
• Distribution: CT, OH, FL, OK, TX, RI, NV, SC,
• 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.