Recall Z-0407-2014— Synthes USA HQ, Inc.

Name: FDA recall Z-0407-2014
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: K033071. Product: Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures. Reason: The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail..

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

K033071 — SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEMSynthes (Usa)·cleared 2003-11-05

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 Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

Reason for recall

The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

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