Synthes, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1915-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 27, 2015

Date Posted: July 8, 2015

Recall Number: Z-1915-2015

Event ID: 71361

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).

Status: Terminated

Product Quantity: 276

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

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated