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Devices
Synthes TI MIRS Polyaxial Screw Body, Part Number 04.631.500
Model / Serial
All lots
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
Product Description
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 || Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Manufacturer
Synthes USA HQ, Inc.
1 Event
Recall of Synthes TI MIRS Polyaxial Screw Body, Part Number 04.631.500
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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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