Recall Z-0387-2014— Synthes USA HQ, Inc.

Name: FDA recall Z-0387-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-31

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-07-31, terminated 2015-06-01. It names one FDA 510(k) clearance: K011857. Product: Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.. Reason: The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Terminated: 2015-06-01
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

Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.

Reason for recall

The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.

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