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Devices
Device Recall Onmifit HFX Hip Stem
모델명 / 제조번호(시리얼번호)
6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 P7MMME, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 RHWMME, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 VJMMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 0J0MNE, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 D9VMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 T9RMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 VK0MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 0HDMNE, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 0HEMNE, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 P7XMME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 RE8MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 REDMME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 VK2MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 VK3MME and 6070-1140A OMNIFIT HFX HIP STEM SIZE #11 132 0HKMNE
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
제품 설명
Omnifit HFX Hip Stem || These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
Device Recall Onmifit HFX Hip Stem 의 리콜
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제조사
Stryker Howmedica Osteonics Corp.
제조사 주소
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
제조사 모회사 (2017)
Stryker
Source
USFDA
Language
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