Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0219-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur

Product Classification:

Class II

Date Initiated: October 29, 2014

Date Posted: November 26, 2014

Recall Number: Z-0219-2015

Event ID: 69685

Reason for Recall:

The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.

Status: Terminated

Product Quantity: 6

Code Information:

part number: 456.316S, lot number: 7782247

Distribution Pattern:

US Distribution in the states of: AK, FL, OH, OK, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated