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OrthoPediatrics Corp recalls OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sl
Recalled January 1, 2014 · FDA recall Z-0579-2014 · OrthoPediatrics
Hazard
Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size. · FDA Class II
Units
40
Sold at
Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
Description
Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
Product
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(s)
OrthoPediatrics Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →