Device product
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.
Z-0133-2013
Product summary
- Event
- Event 63283
- Status
- Terminated
- Classification
- Class II
- Quantity
- 376 units
- Official record key
device-enforcement:Z-0133-2013
Official wording
Reason: 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
Code information: Lot Number: M1108086
Distribution pattern: 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.
Derived failure modes
-
Unknown
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