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Manufacturers
Arthrosurface, Inc.
제조사 주소
Arthrosurface, Inc., 28 Forge Pkwy, Franklin MA 02038
제조사 모회사 (2017)
ArthroSurface
Source
USFDA
6 Events
Device Recall Arthrosurface ToeMotion" 의 리콜
Device Recall The HemiCAP Contoured Articular Prosthetic 의 리콜
Device Recall The HemiCAP Contoured Articular Prosthetic 의 리콜
Device Recall The HemiCAP Contoured Articular Prosthetic 의 리콜
Device Recall The HemiCAP Contoured Articular Prosthetic 의 리콜
Device Recall The HemiCAP Contoured Articular Prosthetic 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 6 건
Device Recall Arthrosurface ToeMotion"
모델명 / 제조번호(시리얼번호)
SN 000242 SN 000244 SN 000246 SN 000247
의료기기 분류등급
Orthopedic Devices
의료기기 등급
Unclassified
이식된 장치?
Yes
유통
US Distribution to the states of : PA, WV and CA.
제품 설명
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 || The component in question is the hex driver (part number 2009-4001).
Device Recall The HemiCAP Contoured Articular Prosthetic
모델명 / 제조번호(시리얼번호)
Catalog Number: 8156-0032, Part Number: 156-0032
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
제품 설명
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Device Recall The HemiCAP Contoured Articular Prosthetic
모델명 / 제조번호(시리얼번호)
Catalog Number: 8135-1875 Part Number: 3135-1875
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
제품 설명
Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Device Recall The HemiCAP Contoured Articular Prosthetic
모델명 / 제조번호(시리얼번호)
Catalog Number: 8135-0032, Part Number: 3135-0032
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
제품 설명
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Device Recall The HemiCAP Contoured Articular Prosthetic
모델명 / 제조번호(시리얼번호)
Catalog Number: 6125-0035, Part Number: 1125-0035
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
제품 설명
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
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