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Manufacturers
U&I; America
Manufacturer Address
U&I; America, 6132 S 380 W Ste 200, Murray UT 84107-6988
Source
USFDA
3 Events
Recall of Spinal fixation system
Recall of Device Recall 4mm Hex Driver
Recall of Device Recall 2.5mm Hex Driver
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3 devices in the database
Spinal fixation system
Model / Serial
Part number SP3020 (revision 6), Lot # 04D033.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
CA
Product Description
Optima Spinal System and Spinal Hook System, set screw component.
Device Recall 4mm Hex Driver
Model / Serial
Part Number MU20012, Revision I, Lot # 02190301, 05120311
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
MN
Product Description
4mm Hex Driver
Device Recall 2.5mm Hex Driver
Model / Serial
Catalog Number OP20004, Lot #04160301 Catalog Number SP00005-US, Lot # O2F108, O2F109, O2G322, O2G323, O2G324, O3E221.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
MN
Product Description
2.5mm Hex Driver
One manufacturer with a similar name
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U&I; America
Manufacturer Address
U&I; America, 6132 South 380 West - Suite 200, Murray UT 840434355
Source
USFDA
Language
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