Stryker Vitallium Wire recall: Sterility Concern
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Why was Stryker Vitallium Wire 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- Product
- Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 3,741 units
- Distribution
- Nationwide Distribution.
- Recall date
- March 2, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)