Stryker Endoscopy

Product Name: SDC HD units and SDC HDi units Model Nuumbers: 240-050-888 and 240-050-888i Code: All SDC HD and SDC HDi units

Radiology Devices

1

No

US government facilities and other US domestic consignees(nationwide), and to foreign countries

An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the surgical procedures in various file formats. Images can be transferred to external media.

Model number: 279-351-300; Lots 11161AE2 to 11241AE2, Lots are numbered sequentially using the middle three numbers, i.e 161-241.

General and Plastic Surgery Devices

2

No

Worldwide distribution including USA, Australia, Canada, China, Greece, Hong Kong, India, Italy, Japan, France, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland and the United Kingdom

Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;

Part number 747-031-650

Orthopedic Devices

2

No

Worldwide distribution: USA including states of: AL, ALASKA, AK, AR, CA, CO, CT, DC, DE, FL, GA, ID IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: Australia, Canada, China, France, Germany, India, Japan, Korea, Latin America, Mexico, Netherlands, Poland, Switzerland and United Kingdom.

Inflow/Outflow Cannula; || Qty: 1; || distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 || The inflow/outflow cannula is intended as a general purpose, concomitant suction and irrigation device for use in endoscopic surgeries. It will be used by orthopedic surgeons in arthroscopic knee and shoulder procedures as well as used in conjunction with the Stryker Flow Control Arthroscopy pump and with all 502-477-xxx scopes. The design included dual scope sheaths made of metal that offer two important features. First, it will separate the inflow irrigation to the operative site from the outflow irrigation out of the operative site. Second, the cannula will have a dual stopcock design that will separately control the inflow and outflow irrigation ports.

PSTR010710-1, PSTR081109-1, PSTR081109-2, PSTR081209-1, PSTR081309-2,  PSTR082109-1, PSTR082709-1, PSTR082809-1, PSTR090809-1, PSTR091809-1,  PSTR091809-2, PSTR092409-1, PSTR100309-1, PSTR100909-1, PSTR110609-1,  PSTRI20709-2, PSTR121809-1, PSTR122209-1, STR021009-8R, STR022709-1R,  STR022709-2R, and STR041709-4R

Gastroenterology-Urology Devices

2

No

Nationwide and 3 foreign consignees (Canada, Singapore and Switzerland).

Stryker Endoscopy, Infravision Esophageal Kit, || Model Numbers: 220180548, 220180540, 220180560

Model number 475-000-000, manufactured between June 2009 and April 2010. All serial numbers are affected.

General and Plastic Surgery Devices

2

No

Worldwide distribution: USA and countries including Australia, France, Germany, Greece, South Africa, Iberia, Italy, New Zealand, Poland, UK, Switzerland, Canada, China, Japan and the EMEA.

Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose || Medical device indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow, wrist and hip. The system provides abrasion, resection, debridement, and removal of bone and soft tissue through its shaver blade and ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its electrosurgical probe. Examples of use include resection, ablation and coagulation of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints. The probe is contraindicated for use in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.