Device Recall Pathfinder NXT

  • 모델명 / 제조번호(시리얼번호)
    Part numbers 3573-2 (straight handle) all lots.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
  • 제품 설명
    Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. || Product Usage: || PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and rods intended to provide temporary stabilization following surgery to fuse the spine. The intended use of the Fixed Angled Percutaneous Rod Inserter is to insert a rod percutaneously through the extender sieeves to position into the implanted screw heads for securing with closure tops forming a construct that provides temporary stabilization following MIS or mini-open surgery to fuse the spine.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 제조사 모회사 (2017)
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Part number 3564-1; all lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
  • 제품 설명
    PathFinder NXT Pivoting Percutaneous Rod Holder || This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part numbers 3573-1 (angle handle) all lots including 64PY, 67YA, 69FF, 71GB, 72JL, 73GY
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
  • 제품 설명
    Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. || Product Usage: || The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimally invasive surgery to fuse the spine. Per the surgical technique (Ll554 Pathfinder NXT Surgical Technique);
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    REF 3566-1 Lots 62TP, 63SG, 65DE, 66CH.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including states of: AZ, CA, WI, MI, KS, OK, TX, GA, TN, FL, NJ, CT, PA and the countries of: Australia and Italy.
  • 제품 설명
    Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN || Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    REF 3566-2 Lots 62TR, 65DD, 66CG.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including states of: AZ, CA, WI, MI, KS, OK, TX, GA, TN, FL, NJ, CT, PA and the countries of: Australia and Italy.
  • 제품 설명
    Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN || Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
  • Manufacturer