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Devices
Device Recall Phantom Fiber Biofiber Sutures
Model / Serial
All lots
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution.
Product Description
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
Recall of Device Recall Phantom Fiber Biofiber Sutures
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Manufacturer
Tornier, Inc
Manufacturer Address
Tornier, Inc, 10801 Nesbitt Ave S, Bloomington MN 55437-3109
Manufacturer Parent Company (2017)
Wright Medical Group NV
Source
USFDA
Language
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