Recall Z-0126-2016— Synthes (USA) Products LLC

Name: FDA recall Z-0126-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-21

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-09-21, terminated 2016-08-26. It names one FDA 510(k) clearance: K131548. Product: Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.. Reason: Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-09-21
Terminated: 2016-08-26
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

Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.

Reason for recall

Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.

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