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Manufacturers
Ortho Solutions Inc
Manufacturer Address
Ortho Solutions Inc, 330 Franklin Tpke, Mahwah NJ 07430-3524
Manufacturer Parent Company (2017)
Ortho Solutions Inc.
Source
USFDA
2 Events
Recall of Oxford/Oxbridge AFN End Cap
Recall of Device Recall FPS 35mm x 3.5 mm nonlocking screw
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2 devices in the database
Oxford/Oxbridge AFN End Cap
Model / Serial
Item Code OS331107 S1009023 Mar-2017 S1009023 Mar-2017 Item Code OS331104 S1009020 Apr-2017 Item Code OS331100 995035 Aug-2017; Jan-2018 Item Code OS331100 S1212114 May-2018 Item Code OS331101 S1009017 Jun-2018 Item Code OS331103 S1009019 Oct-2018 Item Code OS331105 S1102004 Oct-2018 Item Code OS331100 S1307176 Nov-2018, Dec-2018 S1401116 Apr-2019 Item Code OS331103 S1009019 May-2019 Item Code OS331105 S1102004 May-2019 Item Code OOS331100 7802 Oct-2019
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US distribution to MD, NY & PA
Product Description
Oxford/Oxbridge AFN End Cap || 10 mm x 5 mm tp 12 mm x10 mm || The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
Device Recall FPS 35mm x 3.5 mm nonlocking screw
Model / Serial
Part number - OS326835 Lot number: 10100/269A12-68051
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Distribution
Product Description
FPS 35mm x 3.5 mm non-locking screw
One manufacturer with a similar name
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Ortho Solutions Inc
Manufacturer Address
Ortho Solutions Inc, 330 Franklin Tnpk, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Ortho Solutions Inc.
Source
USFDA
Language
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