Devices

Device Recall Stryker AccuLIF PL Cages

  • 모델명 / 제조번호(시리얼번호)
    Catalog #400008 Lot #'s 01141602, 01141607, 01141610, 01141612, 01141617, 02021601, 02021603, 02021605, 02161503. 02161504, 02161506, 02161507, 02161508, 02161509, 02161510, 02161511, 02161512, 02161513, 02161514, 02161515, 03061309, 04161501, 04161502, 04161503, 04161504, 04161505, 04161506, 04161507, 04161508, 05171305, 05181505, 05181506, 05181507, 05181508, 05181509, 05181510, 05181511, 05181512, 05181513, 05181514, 05181515, 06031401, 06031402, 06031403, 06031404, 06201309, 07291404, 07291405, 08191310, 08191311, 08261506, 08261507, 08261508, 10111302, 10111303, 10111304, 10111305, 10291405, 10291406, 11101406, 11101407, 11101408, 11101409, 11101410, 11101411, 11121525, 12151510, 12151515, 12151516, 12151523, 12151526 and 12301315
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    NationwideDistribution
  • 제품 설명
    AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion
  • Manufacturer
    Howmedica Osteonics Corp.
  • 1 Event

제조사

Howmedica Osteonics Corp.
  • 제조사 주소
    Howmedica Osteonics Corp., 2 Pearl Ct, Allendale NJ 07401-1611
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA

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Device Recall Stryker AccuLIF PL Cages
  • 모델명 / 제조번호(시리얼번호)
    Catalog #400006 Lot #'s 01141604, 01141609, 01141614, 01231506, 01231507, 01271513, 01271514, 02021508, 02021509, 02021510, 02021511, 03271306, 04291403, 04291404, 04301513, 04301514, 04301515, 04301516, 06251504, 06291506, 06291507, 06291508, 06291509, 06291510, 06291511, 07081301, 07201503, 07201504, 07201505, 07201506, 08191309, 08251402, 08251403, 09231504, 09251502, 09281510, 10071307, 10071308, 10141504, 10141505, 10261507, 10261508, 11061405, 11061406, 11061407, 11061408, 11121513, 11121517, 11121520, 11121524, 12151512, 12151518, 12151522 and 12301314
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    NationwideDistribution
  • 제품 설명
    AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
  • Manufacturer
    Howmedica Osteonics Corp.
Device Recall Stryker AccuLIF PL Cages
  • 모델명 / 제조번호(시리얼번호)
    Catalog #400010 Lot #'s 01021403, 01121508, 01121509, 01271515, 01271516, 02021512, 02021513, 02021514, 02021515, 02021602, 03221310, 04141508, 04141509, 04141510, 04141511, 04141512, 04251312, 06101405, 06101406, 06101407, 06251311, 07011406, 07201510, 07201511, 07201512, 08141303, 08141313, 09251504, 09281512, 10081301, 10081302, 10201502, 10201503, 10301504, 11121514, 11121518, 11121521, 12151511 and 12151517
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    NationwideDistribution
  • 제품 설명
    AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion
  • Manufacturer
    Howmedica Osteonics Corp.