FDAFDA · Food and drugs·Recall number Z-0133-2013
DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist.
Published October 31, 2012 · Recall initiated: March 12, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Distributor
- Nationwide distribution: USA including states of: AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, NJ, NY, OH, OR, TN, TX, UT, VA, and WA.
- Lot
- Lot Number: M1108086
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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