Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Holt Probe

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Holt Probesee related information
Date Initiated by FirmDecember 22, 2005
Date PostedFebruary 23, 2006
Recall Status1 Terminated 3 on April 06, 2007
Recall NumberZ-0540-06
Recall Event ID 34462
Product Classification Screwdriver - Product Code HXX
ProductHolt Probe Round Straight
Code Information JT05F004
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek Instrument Manufacturing
2975 Brother Blvd
Bartlett TN 38133-3957
For Additional Information ContactBert Kelly
901-396-3133
Manufacturer Reason
for Recall		Depth indicators are incorrectly labeled (etched) on a measurement instrument.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce50 units
DistributionNationwide, Japan, Hong Kong, Australia, The Netherlands Units - Domestic: 31, International: 19
Total Product Life CycleTPLC 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.
-
-