Stryker Vitallium Wire Recalled Due to Sterilization Labeling Error
Stryker is recalling Vitallium Wire because the instructions incorrectly state the non-sterile device is sterile, omitting required sterilization steps.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling error that omits necessary sterilization instructions for a non-sterile device, which fits the criteria for moderate severity.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 3,741 units of Stryker Vitallium Wire (6 Pack) Non Sterile, which is used in bone procedures. The product was distributed nationwide.
The recall was initiated because the enclosed Instructions For Use (IFU) incorrectly state that the device is sterilized via gamma irradiation and should not be resterilized. Although the wire packages are correctly marked with a "NON-STERILE" label, the IFU does not provide instructions for moist heat sterilization, which is required for non-sterile devices.
The affected catalog numbers are 2704-1-024, 2704-3-018, 6703-1-018, 6703-2-120, 6704-1-018, 6704-2-120, and 6704-3-120. Healthcare providers should stop using the affected products and follow the manufacturer's instructions for proper sterilization or return.
The recalled product
- Product
- Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Category
- Medical Device — Orthopedic
- Affected units
- 3,741
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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.
Distribution
Distributed nationwide across the United States.
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