Recall Z-2244-2014— Zimmer, Inc.

Name: FDA recall Z-2244-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-22

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-07-22, terminated 2015-06-18. It names one FDA 510(k) clearance: K112885. Product: Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer. Reason: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-22
Terminated: 2015-06-18
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K112885 — ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLYZimmer, Inc.·cleared 2011-12-19

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

Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer

Reason for recall

Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

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