Devices

Device Recall CrossCHECK Locking Screw

  • 모델명 / 제조번호(시리얼번호)
    CrossCHECK Non-Locking Screw with the following codes: REF CCP-N3008: Lot Numbers: 34996-1, 34996-2, 34996-2-1, 34996; REF CCP-N3010: Lot Numbers: 34996-3, 34996-4, 34996-4-1, 34996; REF CCP-N3012: Lot Numbers: 34996-5, 34996-6, 34996-6-1, 34996; REF CCP-N3014: Lot Numbers: 10157-01, 34996-7, 34996-8, 34996-8-1, 34996; REF CCP-N3016: Lot Numbers: 34996-10, 34996-10-1, 34996-9, 34996; REF CCP-N3018: Lot Numbers: 34996-11, 34996-12, 34996-12-1, 34996; REF CCP-N3020: Lot Numbers: 34996-13, 34996-14, 34996-14-1, 34996; REF CCP-N3022: Lot Numbers: 34996-15, 34996-16, 34996-16-1, 34996; REF CCP-N3024: Lot Numbers: 34996-17, 34996-18, 34996-18-1, 34996; REF CCP-N3026: Lot Numbers: 34996-19, 34996-20, 34996-20-1, 34996; REF CCP-N3028: Lot Numbers: 34996-21, 34996-22, 34996-22-1, 34996; REF CCP-N3030: Lot Numbers: 34996-23, 34996-24, 34996-24-1, 34996; REF CCP-N3032: Lot Numbers: 34996-25, 34996-26, 34996-26-1, 34996; REF CCP-N3034: Lot Numbers: 34996-27, 34996-28, 34996-28-1, 34996; REF CCP-N3036: Lot Numbers: 34996-29, 34996-30, 34996-30-1, 34996; REF CCP-N3038: Lot Numbers: 34996-31, 34996-32, 34996-32-1, 34996; REF CCP-N3040: Lot Numbers: 34996-33, 34996-34, 34996; REF CCP-N3508: Lot Numbers: 1213, 34995-1, 34995-2, 34995; REF CCP-N3510: Lot Numbers: 0114, 34995-3, 34995-4, 34995; REF CCP-N3512: Lot Numbers: 0114, 34995-5, 34995-6, 34995; REF CCP-N3514: Lot Numbers: 0114, 34995-7, 34995-8, 34995; REF CCP-N3516: Lot Numbers: 0114, 34995-10, 34995-9, 34995;  REF CCP-N3518: Lot Numbers: 0114, 34995-11, 34995-12, 34995; REF CCP-N3520: Lot Numbers: 0114, 34995-13, 34995-14, 34995; REF CCP-N3522: Lot Numbers: 0114, 34995-15, 34995-16, 34995; REF CCP-N3524: Lot Numbers: 0114, 34995-17, 34995-18, 34995; REF CCP-N3526: Lot Numbers: 0114, 34995-19, 34995-20, 34995; REF CCP-N3528: Lot Numbers: 34995-21, 34995-22, 34995-22-1, 34995; REF CCP-N3530: Lot Numbers: 34995-23, 34995-24, 34995-24-1, 34995; REF CCP-N3532: Lot Numbers: 34995-25, 34995-26, 34995-26-1, 34995; REF CCP-N3534: Lot Numbers: 34995-27, 34995-28, 34995-28-1, 34995; REF CCP-N3536: Lot Numbers: 34995-29, 34995-30, 34995-30-1, 34995; REF CCP-N3538: Lot Numbers: 34995-31, 34995-32, 34995-32-1, 34995; REF CCP-N3540: Lot Numbers: 34995-33, 34995-34, 34995-34-1, 34995
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 18 mm, REF CCP-N3018; 3.0 x 20 mm, REF CCP-N3020; 3.0 x 22 mm, REF CCP-N3022; 3.0 x 24 mm, REF CCP-N3024; 3.0 x 26 mm, REF CCP-N3026; 3.0 x 28 mm, REF CCP-N3028; 3.0 x 30 mm, REF CCP-N3030; 3.0 x 32 mm, REF CCP-N3032; 3.0 x 34 mm, REF CCP-N3034; 3.0 x 36 mm, REF CCP-N3036; 3.0 x 38 mm, REF CCP-N3038; 3.0 x 40 mm, REF CCP-N3040; 3.5 x 8 mm, REF CCP-N3508; 3.5 x 10 mm, REF CCP-N3510; 3.5 x 12 mm, REF CCP-N3512; 3.5 14 mm, REF CCP-N3514; 3.5 x 16 mm, REF CCP-N3516; 3.5 x 18 mm, REF CCP-N3518; 3.5 x 20 mm, REF CCP-N3520; 3.5 x 22 mm, REF CCP-N3522; 3.5 x 24 mm, REF CCP-N3524; 3.5 x 26 mm, REF CCP-N3526; 3.5 x 28 mm, REF CCP-N3528; 3.5 x 30 mm, REF CCP-N3530; 3.5 x 32 mm, REF CCP-N3532; 3.5 x 34 mm, REF CCP-N3534; 3.5 x 36 mm, REF CCP-N3536; 3.5 x 38 mm, REF CCP-N3538; 3.5 x 40 mm, REF CCP-N3540. The CROSSCHECK Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet wrist and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.
  • Manufacturer
    Wright Medical Technology, Inc.
  • 1 Event

제조사

Wright Medical Technology, Inc.
  • 제조사 주소
    Wright Medical Technology, Inc., 1023 Cherry Rd, Memphis TN 38117-5423
  • 제조사 모회사 (2017)
    Wright Medical Group NV
  • Source
    USFDA

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Device Recall CrossCHECK Locking Screw
  • 모델명 / 제조번호(시리얼번호)
    CrossCHECK Locking Screw with the following codes: REF CCP-L3008: Lot Number 35000; REF CCP-L3010: Lot Number 35000; REF CCP-L3012: Lot Number 35000-6, 35000; REF CCP-L3014: Lot Number 35000-8, 35000; REF CCP-L3016: Lot Number 35000; REF CCP-L3018: Lot Number 35000; REF CCP-L3020: Lot Number 35000; REF CCP-L3022: Lot Numbers: 35000-16-1, 35000; REF CCP-L3024: Lot Number 35000; REF CCP-L3026: Lot Number 35000; REF CCP-L3028: Lot Number 35000; REF CCP-L3030: Lot Number 35000; REF CCP-L3032: Lot Number 35000; REF CCP-L3034: Lot Number 35000; REF CCP-L3036: Lot Number 35000; REF CCP-L3038: Lot Number 35000; REF CCP-L3040: Lot Number 35000; REF CCP-L3508: Lot Number 35004; REF CCP-L3510: Lot Numbers: 35004-3, 35004; REF CCP-L3512: Lot Numbers: 35004-6, 35004; REF CCP-L3514: Lot Numbers: 35004-7, 35004; REF CCP-L3516: Lot Number 35004; REF CCP-L3518: Lot Numbers: 35004-12, 35004-12-1, 35004; REF CCP-L3520: Lot Numbers: 35004-13, 35004; REF CCP-L3522: Lot Numbers: 35004-16-1, 35004; REF CCP-L3524: Lot Numbers: 35004-18-1, 35004; REF CCP-L3526: Lot Number 35004; REF CCP-L3528: Lot Number 35004; REF CCP-L3530: Lot Number 35004; REF CCP-L3532: Lot Number 35004; REF CCP-L3534: Lot Number 35004; REF CCP-L3536: Lot Number 35004; REF CCP-L3538: Lot Number 35004; REF CCP-L3540: Lot Number 35004
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    CrossCHECK Locking Screw in the following sizes: || 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x 24 mm, REF CCP-L3024; 3.0 x 26 mm, REF CCP-L3026; 3.0 x 28 mm, REF CCP-L3028; 3.0 x 30 mm, REF CCP-L3030; 3.0 x 32 mm, REF CCP-L3032; 3.0 x 34mm, REF CCP-L3034; 3.0 x 36 mm, REF CCP-L3036; 3.0 x 38 mm, REF CCP-L3038; 3.0 x 40 mm, REF CCP-L3040; 3.5 x 8 mm, REF CCP-L3508; 3.5 x 10 mm, REF CCP-L3510; 3.5 x 12 mm, REF CCP-L3512; 3.5 x 14mm, REF CCP-L3514; 3.5 x 16 mm, REF CCP-L3516; 3.5 x 18 mm, REF CCP-L3518; 3.5 x 20 mm, REF CCP-L3520; 3.5 x 22 mm, REF CCP-L3522; 3.5 x 24 mm, REF CCP-L3524; 3.5 x 26 mm, REF CCP-L3526; 3.5 x 28 mm, REF CCP-L3528; 3.5 x 30 mm, REF CCP-L3530; 3.5 x 35 mm, REF CCP-L3532; 3.5 x 34 mm, REF CCP-L3534; 3.5 x 36 mm, REF CCP-L3536; 3.5 x 38 mm, REF CCP-L3538; 3.5 x 40 mm, REF CCP-L3540 || The CROSSCHECK Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet wrist and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.
  • Manufacturer
    Wright Medical Technology, Inc.