Device Recall Stryker Orthopaedics Hoffman LRF Telescopic Strut

  • 모델명 / 제조번호(시리얼번호)
    K113327 Catalog No:  Telescopic Strut Extra Short Hoffman LRF Length: 4933-0-100 :100-125mm (Black) 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red);  Lot Code: 4933-0-100 Telescopic Strut Extra Short Hoffman LRF Length 100-125mm (Black) X28937; Z04197; Z09163; Z09597; Z12135;   4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) X28961; Z04199; Z09161; Z09769; Z12012;   4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) X34352; Z04200; Z05068; Z09011; Z09598; Z10872;   4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red); X28963 ;Z04429; Z09471; Z11686
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Hoffman LRF Telescopic Strut Short || Stryker || Stryker Trauma AG || CH-2545 Seizach || Distributed in the USA by || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430. || The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • 제조사 모회사 (2017)
  • Source
    USFDA