Synthes (USA) Products LLC: Medical Device Recall in 2015 - (Recall #: Z-0375-2016)

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:

Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.

Product Classification:

Class II

Date Initiated: November 2, 2015

Date Posted: December 16, 2015

Recall Number: Z-0375-2016

Event ID: 72555

Reason for Recall:

TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.

Status: Terminated

Product Quantity: 5

Code Information:

Part Number Lot Number 04.037.162S 7950511

Distribution Pattern:

US Distribution to states of: CA, FL, MI and WI.

Voluntary or Mandated:

Voluntary: Firm initiated