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.
What this means for you
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.
Related recalls
Same manufacturer · Stryker Howmedica Osteonics Corp.
See all →- HighStryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
FDA (Devices) · 2017-05-31
- SevereStryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
FDA (Devices) · 2017-01-18
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighStryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02