Recall Z-0133-2013— DePuy Mitek, Inc., a Johnson & Johnson Co.
Class II · Terminated
Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2012-03-12, terminated 2015-06-05. It names one FDA 510(k) clearance: K082643. 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.. 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.
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-03-12
- Terminated
- 2015-06-05
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.