Z-0133-2013 Class II Terminated
FDA device recall Z-0133-2013 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Mar 12, 2012 and is designated Class II. 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 The recall status is terminated (terminated Jun 5, 2015). Affected quantity: 376 units.
Recall details
- Product Type
- Devices
- Report Date
- Oct 31, 2012
- Initiation Date
- Mar 12, 2012
- Termination Date
- Jun 5, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 376 units
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
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.
Code information
Lot Number: M1108086
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0133-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026