ClearanceBrief
Recall Z-0558-2010 ยท HAW Neurological Stereotaxic Instrument

Zimmer Inc.

Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains.

DateDec 22, 2009 (initiated Nov 2, 2009)
StatusTerminated
ReasonThe power cord female receptacle is not recessed sufficiently and may present a shock hazard.
Root causeDevice Design
ActionZimmer sales staff were notified by letter dated 11/2/09 and instructed to locate the units and to upgrade the cords and to notify consignees by copy of a letter addressed to risk managers and dated 11/2/09.
Quantity71
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K060336NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
Orthosoft, Inc., Apr 28, 2006
K071714NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
Orthosoft, Inc., Jul 20, 2007
K071929NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
Orthosoft, Inc., Sep 19, 2007