Device Recall EXACTECH

제조사

  • 제조사 주소
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 6 건

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  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.
  • 제품 설명
    Equinoxe 44mm Short Humeral Head || Catalog Number 310-01-44. || Orthopedic shoulder implant component.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 28202, Lot Number AS05107
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of FL, GA, IL, NY, TX, and WA.
  • 제품 설명
    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. || Intended to provide immobilization and stabilization of spinal segments.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog #: 161-30-00 with the manufacturing lots #'s 38878-001, 38878-002, 49777-001, 51825-005, 51825-006, 52224-007, 51825-006, 52224-005, 52224-006, 57167-001, 59775-003, 62580-004, 66464-003, 66464-004, 70720-001, 71530-001, 73477-002, 75153-001, and 74999-001.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA, WI, Hawaii., and to the countries of : Argentina, Australia, Austria, Brazil, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Spain, Switzerland, Turkey, and United Kingdom
  • 제품 설명
    Exactech 1.5" Novation Calcar Planer Guide Tip || To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. || ech 1.5" Novation Calcar Planer Guide Tip
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom
  • 제품 설명
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
  • 제품 설명
    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
  • Manufacturer
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