Recall Z-2247-2014— Zimmer, Inc.

Name: FDA recall Z-2247-2014
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: 6.5 mm Cancellous Screw 16 mm Thread Length 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

6.5 mm Cancellous Screw 16 mm Thread Length 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.