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Class 2 Device Recall Implant Hollow Reamer, 14 mm |
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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
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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
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For Additional Information Contact |
Bert Kelly 901-396-3133
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Manufacturer Reason for Recall |
Bone reamer may not have a cutting surface on the tip.
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FDA Determined Cause 2 |
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
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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.
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