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U.S. Department of Health and Human Services

Class 2 Device Recall Holt Probe

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  Class 2 Device Recall Holt Probe see related information
Date Initiated by Firm December 22, 2005
Date Posted February 23, 2006
Recall Status1 Terminated 3 on April 06, 2007
Recall Number Z-0540-06
Recall Event ID 34462
Product Classification Screwdriver - Product Code HXX
Product Holt Probe Round Straight
Code Information JT05F004
Recalling Firm/
Medtronic Sofamor Danek Instrument Manufacturing
2975 Brother Blvd
Bartlett TN 38133-3957
For Additional Information Contact Bert Kelly
Manufacturer Reason
for Recall
Depth indicators are incorrectly labeled (etched) on a measurement instrument.
FDA Determined
Cause 2
Action The firm notified its direct consignees of the problem with the product and requested the return of any inventory via letter dated 12/22/05.
Quantity in Commerce 50 units
Distribution Nationwide, Japan, Hong Kong, Australia, The Netherlands Units - Domestic: 31, International: 19
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.