Devices

Smith & Nephew

  • 모델명 / 제조번호(시리얼번호)
    All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.
  • 제품 설명
    ULTRA-FAST FIX Knot Pusher Suture Cutters || Product Number: 72201537 || Intended for Meniscal Repair.
  • Manufacturer
    Smith & Nephew, Inc.
  • 1 Event

제조사

Smith & Nephew, Inc.
  • 제조사 주소
    Smith & Nephew, Inc., 150 Minuteman Rd, Andover MA 01810-1031
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA

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Device Recall Smith & Nephew
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 50102446
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    NC, PR
  • 제품 설명
    Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) || Reference Number: 7210430
  • Manufacturer
    Smith & Nephew, Inc., Endoscopy Div.
Device Recall Smith & Nephew FASTFIX
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 50141993, 50145519, 50146091,50146096, 50146362, 50148283, 50146365, 50153066, 50150381
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Foreign: Austria, Germany, France, Italy, Australia
  • 제품 설명
    FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. || Product Number: 7209399
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division
Device Recall Smith & Nephew
  • 모델명 / 제조번호(시리얼번호)
    Product distributed prior to May 5, 2006
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution ---- including states of NM, MO, and TN.
  • 제품 설명
    Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: || Perineal Post 72200631 || Universal Hip Distractor 72200626 || Knee Holder 72200627 || Well Leg Holder 72200632 || Supine Table Extension 72200629
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division
Device Recall Smith & Nephew
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: All lot numbers lower than 50165371 Expanded Recall: Lot Numbers: 50172224, 50173178, 50173179, 50174332, 50174790, 50175034, 50175829, 50175830
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.
  • 제품 설명
    4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box || Part Number: 7209514
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division
Device Recall Smith & Nephew
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: All lot numbers lower than 50165180 Expanded Recall:  Lot Numbers: 50165181, 50168833, 50170484, 50170485, 50173279, 50175080, 50175934, 50175936, 50176896
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.
  • 제품 설명
    5.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box || Part Number: 7209515
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division
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