Recall Z-0474-2014— Synthes USA HQ, Inc.

Name: FDA recall Z-0474-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-30

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-07-30, terminated 2015-09-10. It names one FDA 510(k) clearance: K011857. Product: 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.. Reason: 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..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Terminated: 2015-09-10
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K011857 — SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEMSynthes (Usa)·cleared 2001-09-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.