ClearanceBrief
Recall Z-0540-06 ยท HXX Screwdriver

Medtronic Sofamor Danek Instrument Manufacturing

Holt Probe Round Straight

DateFeb 23, 2006 (initiated Dec 22, 2005)
StatusTerminated
ReasonDepth indicators are incorrectly labeled (etched) on a measurement instrument.
Root causeOther
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.
Quantity50 units
DistributionNationwide, Japan, Hong Kong, Australia, The Netherlands Units - Domestic: 31, International: 19
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.