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Devices
Device Recall Phantom Fiber Biofiber Sutures
모델명 / 제조번호(시리얼번호)
All lots
의료기기 분류등급
General and Plastic Surgery Devices
의료기기 등급
2
이식된 장치?
Yes
유통
US Nationwide Distribution.
제품 설명
Fornier Phantom Fiber(TM) Sutures: || Item Number Description || SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES || SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES || SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES || SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES || SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE || SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED || SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE || SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED || SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET || SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED || SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET || SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED || SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET || SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET || Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Manufacturer
Tornier, Inc
1 Event
Device Recall Phantom Fiber Biofiber Sutures 의 리콜
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제조사
Tornier, Inc
제조사 주소
Tornier, Inc, 10801 Nesbitt Ave S, Bloomington MN 55437-3109
제조사 모회사 (2017)
Wright Medical Group NV
Source
USFDA
Language
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