Z-0479-2016 Class II Terminated
FDA device recall Z-0479-2016 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Nov 23, 2015 and is designated Class II. Reason for recall: Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the… The recall status is terminated (terminated Apr 12, 2017). Affected quantity: 127.
Recall details
- Product Type
- Devices
- Report Date
- Dec 30, 2015
- Initiation Date
- Nov 23, 2015
- Termination Date
- Apr 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127
Product description
VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Reason for recall
Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only
Distribution pattern
Worldwide Distribution - US Distribution to the states of : AL, CA, CT, FL, KY, MN, MS, ND, NJ, NM and TX., and to the countries of: France, Netherlands and Norway.
Code information
U1509202 and U1509162
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0479-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026