Device Recall CrossCHECK Locking Screw

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Wright Medical Technology, Inc., 1023 Cherry Rd, Memphis TN 38117-5423
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

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  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    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