Reported Mar 2, 2016 · Terminated
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
- Lot codes and dates
- All
- lots of the following Catalog Numbers
2704-1-0242704-3-0186703-1-0186703-2-1206704-1-0186704-2-120 and 6704-3-120
- Amount recalled
- 3,741 units
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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