FDA-Device2015-07-08Class II
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
Synthes, Inc.
Hazard
certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).
Sold states
Nationwide Distribution.
Affected count
276
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1915-2015Don't want to check this manually?
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