Z-2031-2013Class II

90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR...

Name: Z-2031-2013 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR...
Creator: Zimmer, Inc.
Published: 2013-06-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-06-07 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112... on 2013-06-07. FDA classified it as Class II and gives the reason as "Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2031-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Posted: 2013-08-22
Terminated: 2014-12-15
Recalling firm: Zimmer GmbH
Product: 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/STR GRN 14MM, Rx, Sterile; 90597004117 Articular Surface CR ART SURF AE56/STR GRN 17MM, Rx, Sterile; 90597004120 Articular Surface CR ART SURF AE56/STR GRN 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.
Quantity in commerce: 192,355 all devices
Distribution: Worldwide Distribution-USA (nationwide) and the country of Japan.
Product codes and lots: all codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2031-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1998-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-1999-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2000-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2001-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2002-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2003-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2004-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2005-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2006-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2007-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2008-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2009-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2010-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2011-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2012-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2013-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2014-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2015-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2016-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2017-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2018-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2019-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2020-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2021-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2022-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2023-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2024-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2025-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2026-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2027-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2028-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2029-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2030-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2031-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2032-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2033-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2034-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2035-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2036-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2037-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2038-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2039-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2040-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2041-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2042-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2043-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22
Z-2044-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-22

Product code JWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)