Orthosoft, Inc. dba Zimmer CAS

6 devices in the database

  • Model / Serial
    Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand
  • Product Description
    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument || CAS Software application intended to assist in the placement of total knee replacement components
  • Model / Serial
    Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3 ORTHOsoft-UniTkr- 2.1.6.0.2 OsUniTkr (previous naming convention for ORTHOsoft-UniTkr)- D.54, A.42
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New Zealand Spain Sweden Switzerland United Kingdom
  • Product Description
    Navitrack System - OS Knee Universal, Stereotaxic instrument
  • Model / Serial
    Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI Foreign: Germany, Spain, Czech Republic, Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, United Kingdom
  • Product Description
    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
  • Model / Serial
    Part Number: NDI P7 Position Sensor Product Number 201.053 (a component of part number 521.035, Sesamoid Plasty Camera Arm Kit) Lot/Serial Number: 38 units affected: P7-00321, P7-00339, P7-00360, P7-00361, P7-00362, P7-00363, P7-00364, P7-00365, P7-00366, P7-00368, P7-00369, P7-00370, P7-00371, P7-00372, P7-00373, P7-00375, P7-00387, P7-00412, P7-00414, P7-00415, P7-00416, P7-00417, P7-00418, P7-00419, P7-00420, P7-00421, P7-00422, P7-00423, P7-00431, P7-00451, P7-00452, P7-00453, P7-00562, P7-00563, P7-00565, P7-00568, P7-00569, P7-00590 (The lot number and the serial number are the same)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : KS, MS, WI, NJ, KS, IN, LA, FL and WA., and to the countries of : Canada, Australia, Singapore, Netherlands, UK, Austria, Germany, Switzerland and Czech Republic.
  • Product Description
    NDI P7 Position Sensor, Stereotaxic Instrument
  • Model / Serial
    Part Number and : 521.025/521.028; Lot Number/Serial Numbers: SP-001, SP-002, SP-003, SP-004, SP-005, SP-006,  SP-007, SP-008, SP-009, SP-010
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil
  • Product Description
    Sesamoid Plasty, Stereotaxic Instrument || The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
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