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FDA device recall Z-0540-06 · posted 2006-02-23 · Terminated

Recall details

Recalling firm
Medtronic Sofamor Danek Instrument Manufacturing
Reason for recall
Depth indicators are incorrectly labeled (etched) on a measurement instrument.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
HXX
Quantity affected
50 units
Distribution
Nationwide, Japan, Hong Kong, Australia, The Netherlands Units - Domestic: 31, International: 19
Date initiated
2005-12-22
Date posted
2006-02-23
Date terminated
2007-04-06
Location
Bartlett, TN

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