Recall Z-0537-2013— Zimmer, Inc.

Name: FDA recall Z-0537-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-19

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2012-11-19, terminated 2014-04-17. It names one FDA 510(k) clearance: K973357. Product: COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.. Reason: Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit ..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-11-19
Terminated: 2014-04-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K973357 — COONRAD/MORREY TOTAL ELBOW, NEW HINGE PINZimmer, Inc.·cleared 1998-03-02

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

COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.

Reason for recall

Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .

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