Z-1915-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2015
- Initiation Date
- May 27, 2015
- Termination Date
- December 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 276
Product Description
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.
Reason for Recall
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).
Distribution Pattern
Nationwide Distribution.
Code Information
Part Numbers : 04.003.024 04.003.025 04.003.026 04.003.027 04.003.028 04.003.029 04.003.031 with Lot Numbers: 8638958 8638957 8534954 8638955 8556020 8556018 8653032 8653036