Z-1037-2014Class II

FEM HD ION (various sizes)

Name: Z-1037-2014 FEM HD ION (various sizes)
Creator: Zimmer, Inc.
Published: 2013-10-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-10-11 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of FEM HD ION (various sizes) on 2013-10-11. FDA classified it as Class II and gives the reason as "Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1037-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-11
Posted: 2014-02-20
Terminated: 2017-04-14
Recalling firm: Zimmer GmbH
Product: FEM HD ION (various sizes)
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Root cause tag: packaging
FDA root cause: Packaging
Action: Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.
Quantity in commerce: 7,044,680 total
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
Product codes and lots: 61401713 60282649 60291491 60362702 60586125 60977398 61089134 62051714 60530561 60759915 60939995 61275826 60169621

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1037-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1001-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1002-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1003-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1004-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1005-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1006-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1007-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1008-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1009-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1010-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1011-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1012-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1013-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1014-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1015-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1016-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1017-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1018-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1019-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1020-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1021-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1022-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1023-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1024-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1025-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1026-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1027-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1028-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1029-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1030-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1031-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1032-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1033-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1034-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1035-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1036-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1037-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1038-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1039-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1040-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1041-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1042-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1043-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20
Z-1044-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20

Product code JWH

K892800Class IIMg II Porous Total Knee SystemZimmer, Inc. / cleared 1989-08-03

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)