Stryker Instruments Div. of Stryker Corporation

All units.

Neurological Devices

2

No

Worldwide- USA and countries of Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Mexico, New Zealand, South Korea, Switzerland and United Kingdom.

Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000.

Serial Number(s) Affected: 10897, 10898, 10899, 10900, 10901, 10902, 10903, 10904, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10917, 10919, 10920, 10921, 10922, 10923, 10925, 10926, 10927, 10928. Product Code (UDI): (01)04546540503824

Neurological Devices

2

No

International , US and US Govt.

The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of || the navigation software and creation of a pathway into the pedicle. The instrument has three || types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The || Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler || tip has been inserted into the pedicle. Next to the navigational information, these depth || indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.

RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U

Neurological Devices

2

No

Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign:France, Germany, Canada, UK, Lebanon, South Africa, Chile, Hong Kong, Poland, Argentina, Spain, Greece, Italy, India, Brazil, Switzerland, Netherlands, Sweden VA/DOD:

RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

Part Number 7222-120-000; All lot numbers from 13072 to 14121

Orthopedic Devices

1

No

Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.

Stryker SmartLife Small Aseptic Housing || REF 7222-120-000 || Rx Only || The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.

Part Number 7126-120-000; All lot numbers from 13027 to 14093

Orthopedic Devices

1

No

Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.

Stryker SmartLife Large Aseptic Housing || REF 7126-120-000 || Rx Only || The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.