Recall Z-2475-2015— Synthes (USA) Products LLC

Name: FDA recall Z-2475-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-22

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-07-22, terminated 2016-08-18. It names one FDA 510(k) clearance: K110789. Product: Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. Reason: The end cap may loosen and detach making the instrument non-functional. No injuries reported..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-07-22
Terminated: 2016-08-18
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K110789 — SYNTHES STERNAL ZIPFIX SYSTEMSynthes (Usa)·cleared 2011-07-28

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 Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

Reason for recall

The end cap may loosen and detach making the instrument non-functional. No injuries reported.

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