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Devices
Device Recall Synthes Midfoot Fusion Bolt
Model / Serial
Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
Product Description
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Manufacturer
Synthes USA HQ, Inc.
1 Event
Recall of Device Recall Synthes Midfoot Fusion Bolt
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Manufacturer
Synthes USA HQ, Inc.
Manufacturer Address
Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA
Language
English
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