CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report
Stryker Vitallium Wire Non Sterile recalled
Stryker Howmedica Osteonics is recalling Stryker Vitallium Wire Non Sterile, distributed nationwide in the US. The recall was initiated on 23 Dec 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0855-2016
- FDA event ID
- 73042
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2015
- FDA classified
- 23 Feb 2016
- Reported
- 2 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Dec 2015 | Recall initiated by company | |
| 23 Feb 2016 | Classified by FDA | +62 days |
| 2 Mar 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is Stryker Vitallium Wire Non Sterile recalled?
Yes. Stryker Howmedica Osteonics recalled Stryker Vitallium Wire Non Sterile on 23 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0855-2016.
Why was it 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.
Which lots are affected?
All lots of the following Catalog Numbers: 2704-1-024; 2704-3-018; 6703-1-018; 6703-2-120; 6704-1-018; 6704-2-120 and 6704-3-120.
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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