Z-0075-2014Class II

Natural-Knee Flex Femoral Component. Provides increased flexion capability

Name: Z-0075-2014 Natural-Knee Flex Femoral Component. Provides increased flexion capability
Creator: Zimmer, Inc.
Published: 2013-08-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-08-30 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of Natural-Knee Flex Femoral Component. Provides increased flexion capability on 2013-08-30. FDA classified it as Class II and gives the reason as "The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices". 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-0075-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Posted: 2013-10-25
Terminated: 2014-09-25
Recalling firm: Zimmer GmbH
Product: Natural-Knee Flex Femoral Component. Provides increased flexion capability.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.
Quantity in commerce: 33987
Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
Product codes and lots: Part Number Range: 00-5410,5412,5414,and 5416-013/018-01/02.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0075-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0068-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0069-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0070-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0071-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0072-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0073-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0074-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0075-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0076-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0077-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0078-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0079-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25
Z-0080-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25

Product code JWH

K936159Class IINatural-Knee II SystemIntermedics Orthopedics / cleared 1995-05-22

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)