Devices

Device Recall Robotic Arm Interactive Orthopedic System

  • 모델명 / 제조번호(시리얼번호)
    Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.
  • 제품 설명
    Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
  • Manufacturer
    Mako Surgical Corporation
  • 1 Event

제조사

Mako Surgical Corporation
  • 제조사 주소
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Plantation FL 33317-7424
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA

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

데이터에 대해 더 자세히 알아보기 여기

Device Recall Robotic Arm Interactive Orthopedic System (RIO)
  • 모델명 / 제조번호(시리얼번호)
    All lots, Part Numbers: 201000, 203999, 207300, and 209930.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.
  • 제품 설명
    Restoris Partial Knee Application (PKA) RIO (TGS 2.0). || For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
  • Manufacturer
    Mako Surgical Corporation