Synthes, Inc. recalls DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Exp…

Recall date

May 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1915-2015

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

Nationwide Distribution.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.