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U.S. Department of Health and Human Services

Class 2 Device Recall Implant Hollow Reamer, 14 mm

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  Class 2 Device Recall Implant Hollow Reamer, 14 mm see related information
Date Initiated by Firm August 01, 2006
Date Posted October 19, 2006
Recall Status1 Terminated 3 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/
Medtronic Sofamor Danek Instrument Manufacturing
2975 Brother Blvd
Bartlett TN 38133-3957
For Additional Information Contact Bert Kelly
Manufacturer Reason
for Recall
Bone reamer may not have a cutting surface on the tip.
FDA Determined
Cause 2
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.