Recall Z-1842-2014— Zimmer, Inc.

Name: FDA recall Z-1842-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-19

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-05-19, terminated 2015-03-24. It names one FDA 510(k) clearance: K973714. Product: VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581. Reason: During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Terminated: 2015-03-24
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K973714 — VERSYS HIP SYSTEM BEADED HIP PROSTHESISZimmer, Inc.·cleared 1997-12-24

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

VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581

Reason for recall

During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.

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