Class 2 Device Recall Implant Hollow Reamer, 14 mm

• Date Initiated by Firm: August 01, 2006
• Date Posted: October 19, 2006
• Recall Status: Terminated on April 04, 2007
• Recall Number: Z-0050-2007
• Recall Event ID: 36123
• Product Classification: bone reamer - Product Code HTO
• Product: Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic).
• Code Information: Lot Nos.: CN04J012, CN06A003
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek Instrument Manufacturing; 2975 Brother Blvd; Bartlett TN 38133-3957
• For Additional Information Contact: Bert Kelly; 901-396-3133
• Manufacturer Reason for Recall: Bone reamer may not have a cutting surface on the tip.
• FDA Determined Cause: Other
• Action: The firm notified its hospital consignees by letter dated 08/01/2006. The letter requested cessation of use and return.
• Quantity in Commerce: 9 units
• Distribution: Nationwide
• 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.