Devices

Device Recall ACL Reconstruction System Installation tools

Model / Serial
Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
Product Description
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. || Used with ACL reconstruction system associated surgery.
Manufacturer
OrthoPediatrics Corp
1 Event
- Recall of Device Recall ACL Reconstruction System Installation tools

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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