FDA-Device2014-09-10Class II
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
OrthoPediatrics Corp
Hazard
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Sold states
US Nationwide Distribution.
Affected count
56 units
Manufactured in
2850 Frontier Dr, Warsaw, IN, United States
Products
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2560-2014Don't want to check this manually?
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