Devices

Device Recall Stryker

  • 모델명 / 제조번호(시리얼번호)
    Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.
  • 제품 설명
    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. || Product Usage: || The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event

제조사

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 499 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Stryker
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number- 33250400S Catalog Number 33250360S
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution including the states of IL, KY and TN.
  • 제품 설명
    GAMMA3 System Long Nail Kit, R2.0, Ti, Left || Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA || A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Stryker brand Neuroform 3 Microdelivery Stent System
  • 모델명 / 제조번호(시리얼번호)
    Code: M003450200, Lot 15391019, Expiration Date: 2015-07
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    HDE
  • 이식된 장치?
    Yes
  • 유통
    International Distribution including Austria, China, and Germany.
  • 제품 설명
    Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA || The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.
  • Manufacturer
    Stryker Neurovascular
Device Recall Stryker Spine Oasys Midline Occiput Plate
  • 모델명 / 제조번호(시리얼번호)
    K093670   Catalog numbers:  Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048  All lots of the above
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long || 5) Mini. || Allows for positioning directly on the midline keel of the occiput.
  • Manufacturer
    Stryker Spine
Device Recall Stryker Visum 300
  • 모델명 / 제조번호(시리얼번호)
    Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US natiowide and to the country of Canada.
  • 제품 설명
    Stryker Visum 300 Ceiling-mounted Exam Light.
  • Manufacturer
    Stryker Communications
Device Recall Stryker Orthopaedics
  • 모델명 / 제조번호(시리얼번호)
    Catalog #6541-2-609 All lot codes
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
하나 더 494 건 더