Omnifit HA Hip Stem recallZ-0891-2009 · 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-0891-2009
- 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
- MEH
- FDA submissions
- K982032
- Distribution
- Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
Product description
Omnifit 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 revision total hip arthroplasty.
Code information (models, lots, serial numbers)
x6017-0525A OMNIFIT HA HIP STEM #5 3PMMNE and 6017-1035A OMNIFIT HA HIP STEM #10 NKAMME
Other devices under the same FDA submission
3 devices cleared under K982032 — 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 6017-0935AHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- Omnifit 6017-0525AHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Omnifit 6017-0625AHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 50485).
- 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-0896-2009 · TerminatedOmnifit 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…
- 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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