Recall Z-1496-2014— Zimmer, Inc.

Name: FDA recall Z-1496-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-01

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-04-01, terminated 2014-09-11. It names one FDA 510(k) clearance: K021891. Product: TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.. Reason: The shell was missing the locking ring..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-01
Terminated: 2014-09-11
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K021891 — ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEMZimmer, Inc.·cleared 2002-09-05

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

TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.

Reason for recall

The shell was missing the locking ring.

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