Z-0896-2009

Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are...

Name: Z-0896-2009 Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-11-13
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-11-13 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular... on 2008-11-13. The reason FDA records is "Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain 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-0896-2009
Status: Terminated
Initiated: 2008-11-13
Posted: 2009-01-26
Terminated: 2010-01-20
Recalling firm: Howmedica Osteonics Corp
Product: Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
Root cause tag: packaging
FDA root cause: Packaging
Action: Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.
Quantity in commerce: 322 total units - all types
Distribution: Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
Product codes and lots: 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 P7MMME, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 RHWMME, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 VJMMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 0J0MNE, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 D9VMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 T9RMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 VK0MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 0HDMNE, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 0HEMNE, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 P7XMME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 RE8MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 REDMME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 VK2MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 VK3MME and 6070-1140A OMNIFIT HFX HIP STEM SIZE #11 132 0HKMNE

Product code JDI

K031744Class IIOmnifit Hfx Hip Stem SeriesHowmedica Osteonics Corp. / cleared 2003-08-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)