Devices

Device Recall 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm

Model / Serial
Lot 009SV
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
Product Description
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm || Part No. 00-0903-2620 || OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
Manufacturer
OrthoPediatrics Corp
1 Event
- Recall of Device Recall 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm

Manufacturer

OrthoPediatrics Corp

Manufacturer Address
OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
Manufacturer Parent Company (2017)
Orthopediatrics Corp
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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