Devices

Device Recall LUSTER HIP

  • 모델명 / 제조번호(시리얼번호)
    Product code:152180007 and Lot numbers: A1XEF1000, A21BV1000, A4NBV1000, A6BB31000, AB1H31000, AV1A71000, AV7FL1000, BB8E21000, BV8FT1000, VG3BSB000, X5XD21000, Y64ET1000, Z12DG1000, and Z1PJE1000.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • 제품 설명
    LUSTER HIP SZ 7 || Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. || Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event

제조사

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

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Device Recall LUSTER HIP
  • 모델명 / 제조번호(시리얼번호)
    Product code: 152180001 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • 제품 설명
    LUSTER HIP SZ 1 || Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. || Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
    DePuy Orthopaedics, Inc.
Device Recall LUSTER HIP
  • 모델명 / 제조번호(시리얼번호)
    Product code:152180002 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • 제품 설명
    LUSTER HIP SZ 2 || Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. || Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
    DePuy Orthopaedics, Inc.
Device Recall LUSTER HIP
  • 모델명 / 제조번호(시리얼번호)
    Product code:152180003 and Lot numbers: A46D71000, A52C11000, A88D11000, AY2CE1000, B1XGV1000, BA3BF1000, BC6BC1000, BX9B71000, Y97FM1000, and Z5NBJ1000.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • 제품 설명
    LUSTER HIP SZ 3 || Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. || Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
    DePuy Orthopaedics, Inc.
Device Recall LUSTER HIP
  • 모델명 / 제조번호(시리얼번호)
    Product code:152180004 and Lot numbers: A4VCX1000, A55MG1000, A88F41000, AT4FH1000, BC5E51000, BJ4JP1000, BS3FN1000, BX9B81000, and ZV1FH1000.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • 제품 설명
    LUSTER HIP SZ 4 || Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. || Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
    DePuy Orthopaedics, Inc.
Device Recall LUSTER HIP
  • 모델명 / 제조번호(시리얼번호)
    Product code:152180005 and Lot numbers: AH7DVA000 and VJ3B21003.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
  • 제품 설명
    LUSTER HIP SZ 5 || Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. || Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
  • Manufacturer
    DePuy Orthopaedics, Inc.
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