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Devices
Intraosseous Fixation System
Model / Serial
Part #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.
Product Description
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. || Intended to stabilize and aid in fixation of fractures.
Manufacturer
Orthohelix Surgical Designs Inc
1 Event
Recall of Intraosseous Fixation System
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Manufacturer
Orthohelix Surgical Designs Inc
Manufacturer Address
Orthohelix Surgical Designs Inc, 1065 Medina Rd Ste 500, Medina OH 44256-5376
Manufacturer Parent Company (2017)
Wright Medical Group NV
Source
USFDA
Language
English
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