Recall Z-2091-2015— Synthes (USA) Products LLC

Name: FDA recall Z-2091-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-10

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-06-10, terminated 2016-08-18. It names one FDA 510(k) clearance: K131548. Product: Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.. Reason: The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017)..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-06-10
Terminated: 2016-08-18
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K131548 — SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEMSynthes (USA) Products, LLC·cleared 2014-02-28

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

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.

Reason for recall

The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).

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