Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0474-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
Product Description:

Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

Product Classification:

Class II

Date Initiated: July 30, 2013
Date Posted: December 18, 2013
Recall Number: Z-0474-2014
Event ID: 66409
Reason for Recall:

Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

Status: Terminated
Product Quantity: 12
Code Information:

Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

Distribution Pattern:

Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

Voluntary or Mandated:

Voluntary: Firm initiated