Devices

Device Recall Black Widow Buttress Plate and Screw

  • 모델명 / 제조번호(시리얼번호)
    Part Number TBS020 Lot Number 0825R, NM01836, WT090314A, 09281, 09282, 09285, WT040412A, 08344, 09154, 09281R, NM01836R; Part Number TBS025 Lot Number 09161, 09286R, WT090314B, WT112613B, 08218, 08337, 09287R, NM01837, 08216; Part Number TBS030 Lot Number 08218, WT011711B, WT071014A
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to IN, LA, and TX
  • 제품 설명
    Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 || The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
  • Manufacturer
    Amendia, Inc
  • 1 Event

제조사

Amendia, Inc
  • 제조사 주소
    Amendia, Inc, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • 제조사 모회사 (2017)
    Spinal Elements
  • Source
    USFDA

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Device Recall Black Widow Buttress Plate and Screw
  • 모델명 / 제조번호(시리얼번호)
    Part Number TBP119  Lot Number WT103014B, WT112210B, 01838, WT111213A, WT040813A, WT042213C; Part Number TB123  Lot Number NM01839, WT080112A, WT081712E, WT112210C, WT112113A, WT112713B, WT110714A, WT1127, 09286, WT041213A, WT112713
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to IN, LA, and TX
  • 제품 설명
    Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 || The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
  • Manufacturer
    Amendia, Inc