Device Recall ATTUNE" Articulation Surface

  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 254500503, 254500504, 254500505, 254500506, 254500507, and 254500508. GTIN: 10603295132431, 10603295132448, 10603295132455, 10603295132462, 10603295132479, and 10603295132486.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including 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, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
  • 제품 설명
    ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 9 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 254500523, 254500524, 254500525, 254500526, 254500527, and 254500528. GTIN: 10603295132639, 10603295132646, 10603295132653, 10603295132660, 10603295132677, and 10603295132684.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including 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, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
  • 제품 설명
    ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 254500543, 254500544, 254500545, 254500546, 254500547, and 254500548. GTIN: 10603295132837, 10603295132844, 10603295132851, 10603295132868, 10603295132875, and 10603295132882.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including 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, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
  • 제품 설명
    ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Codes:254500981, 254500982, 254501989, and 254501990. GTIN: 10603295135586, 10603295135593, 10603295423492, and 10603295423959.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including 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, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
  • 제품 설명
    ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 254500563, 254500564, 254500565, 254500566, 254500567, and 254500568. GTIN: 10603295133032, 10603295133049, 10603295133056, 10603295133063, 10603295133070, and 10603295133087.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including 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, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
  • 제품 설명
    ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product Codes:254500971, 254500972, 254500973, 254500974, 254500975, 254500976, 254500977, 254500978, 254500979, and 254500980. GTIN: 10603295135487, 10603295135494, 10603295135500, 10603295135517, 10603295135524, 10603295135531, 10603295135548, 10603295135555, 10603295135562, and 10603295135579.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including 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, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
  • 제품 설명
    ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
  • Manufacturer
하나 더 4 건 더