Omnifit HFX Hip Stem recallZ-0896-2009 · Stryker Howmedica Osteonics Corp. · initiated Nov 13, 2008
Terminated All recalls posted in January 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
FDA root cause category: Packaging
What the company is doing
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.
Recall details
- Recall number
- Z-0896-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 13, 2008
- Posted by the FDA
- Jan 26, 2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 322 total units - all types
- Product code
- JDI
- FDA submissions
- K031744
- Distribution
- Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
Product description
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.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Other devices under the same FDA submission
6 devices cleared under K031744 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Omnifit 6070-0730AHowmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 reports
- Omnifit 6076-0730AHowmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 reports
- Omnifit 6076-0830AHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented2 reports
- Omnifit 6070-1035AHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Omnifit 6070-0935AHowmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 report
- Omnifit 6076-0525AHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 50485).
- Z-0891-2009 · TerminatedOmnifit HA 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 …
- Z-0893-2009 · TerminatedSecur-Fit Max 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…
- Z-0894-2009 · TerminatedPrimary Secur-fit Plus Max Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular componen…
- Z-0898-2009 · TerminatedOmnifit FC Cemented 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 prima…
- Z-0899-2009 · TerminatedOmnifit Eon 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 revisio…
- Z-0902-2009 · TerminatedSecur-Fit ARC/HA Collar 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 p…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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