Device Recall Stryker

Part Number 0505-585-000, Lot 11223012  13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012

Orthopedic Devices

1

No

Nationwide Distribution including FL, PA, NY, OH, IL, KY, MT, WA, CA, MO, HI, IN, SC, MS, WV, KS, TX, and WY

Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI || Part Number: 0505-585-000, Lot:11223012 || 13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 || 13G Bevel Tip Stylet - PIN 0306-131-012 || The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) including the states of: 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: DEDEDO GU, HAMILTON ON, SANTIAGO, SHATIN, NT , CAPITOL FEDERAL, ITAPEVI SP, ATHENS, OSAKA, SEOUL, MEXICO DF MX, MONTREUX, BALERNA, NORTH POINT, WARSZAWA, CANOVANAS, KOWLOON BAY, SINGAPORE, NEWBURY, and JOHANNESBURG.

Stryker Epic Zoom Critical Care Bed -Model 2040, 115 V, 500 lbs ( 227 Kg) Stryker, Portage Mi 49002 || Product Usage: || EPIC II (model 2040) Critical Care beds is primarily used in a Critical Care environment, but may be used in Med/Surg environments.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) including the states of: 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: DEDEDO GU, HAMILTON ON, SANTIAGO, SHATIN, NT , CAPITOL FEDERAL, ITAPEVI SP, ATHENS, OSAKA, SEOUL, MEXICO DF MX, MONTREUX, BALERNA, NORTH POINT, WARSZAWA, CANOVANAS, KOWLOON BAY, SINGAPORE, NEWBURY, and JOHANNESBURG.

Stryker Secure 3002, 115 V ~ 60 Hz, 500 lbs ( 227Kg), Stryker, Kalamazoo, MI 49001 || Product Usage: || Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The Secure II model is primarily used in the Med/Surg units, but may also be found in a Critical Care environment.

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General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) including the states of: 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: DEDEDO GU, HAMILTON ON, SANTIAGO, SHATIN, NT , CAPITOL FEDERAL, ITAPEVI SP, ATHENS, OSAKA, SEOUL, MEXICO DF MX, MONTREUX, BALERNA, NORTH POINT, WARSZAWA, CANOVANAS, KOWLOON BAY, SINGAPORE, NEWBURY, and JOHANNESBURG.

Stryker Secure Model 3221, 230 V- 50/60 Hz, 500 lbs (227 Kg) || Stryker, Kalamazoo, MI 49001 || Product Usage: || Secure II (model 3221) Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The Secure II model is primarily used in the Med/Surg units, but may also be found in a Critical Care environment. . Models 3221 represents International Voltage configurations of the 3002 model.

General Hospital and Personal Use Devices

2

No

Worldwide distribution:USA (nationwide) and countries including: Argentina, Bertec, Brasil, Brazil, Canada, Chile, China, India, Latin America, Mexico,Osteonics SA, Polska, Portugal, Puerto Rico, and Singapore.

GoBed+ . Model FL20E || Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone