Devices

Synthes TI MIRS Locking Cap, OneStep Titanium Alloy, Part Number 04.631.502

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 Locking Cap, Part Number 04.631.502 || 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 Locking Cap, OneStep Titanium Alloy, Part Number 04.631.502

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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