Class II — DePuy Mitek, Inc., a Johnson & Johnson Co.
| Recalling firm | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
|---|---|
| Registered facility | DePuy Mitek, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| 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. |
| Quantity | 376 units |
| Distribution | 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. |
| Initiated | 2012-03-12 |
| Classified | 2012-10-24 |
| Terminated | 2015-06-05 |
| Recall number | Z-0133-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DePuy Mitek, Inc., a Johnson & Johnson Co. (Z-0133-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63283/
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