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Devices
Pivot BiPolar Head
Model / Serial
Part 133-2846, Lots 3370, 3534, 3620, 3731 Part 133-2847, Lots 3492, 3535 Part 133-2848, Lot 3509 Part 133-2851, Lot 3433 Part 133-2852, Lot 3661
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
AZ, CA, FL, MA, MI. No military, government or foreign distribution.
Product Description
Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
Manufacturer
Ortho Development Corporation
1 Event
Recall of Pivot BiPolar Head
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Manufacturer
Ortho Development Corporation
Manufacturer Address
Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
Manufacturer Parent Company (2017)
Ortho Development Corporation
Source
USFDA
Language
English
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