Recall Z-0226-2013— Zimmer, Inc.

Name: FDA recall Z-0226-2013
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: K051623, K990136. Product: zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405. 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

K051623 — ANATOMICAL SHOULDER KEELED GLENOIDZimmer GmbH·cleared 2005-07-19
K990136 — ANATOMICA GLENOID COMPONENTSulzer Orthopedics, Inc.·cleared 1999-03-01

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

zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405

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.