Recall Z-0227-2013— Zimmer, Inc.

Name: FDA recall Z-0227-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-04

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2012-09-04, terminated 2014-04-16. It names 2 FDA 510(k) clearances: K062029, K030259. Product: Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem. Reason: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info.

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-04
Terminated: 2014-04-16
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K062029 — ANATOMICAL SHOULDER FRACTURE SYSTEMZimmer GmbH·cleared 2006-10-31
K030259 — AMATOMICAL SHOULDER WITH REMOVABLE HEADCenterplus Orthopedics, Inc.·cleared 2003-04-24

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

Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem

Reason for recall

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

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