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U.S. Department of Health and Human Services

Class 2 Device Recall VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece

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 Class 2 Recall
VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece
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Date Posted October 24, 2012
Recall Status1 Open
Recall Number Z-0133-2013
Recall Event ID 63283
Premarket Notification
510(K) Number
K082643 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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.
Code Information Lot Number: M1108086
Recalling Firm/
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham, Massachusetts 02767
For Additional Information Contact Sandra L. Gelinas
508-977-3813
Manufacturer 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
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action The firm, Depuy Mitek, sent a "Medical Device Labeling Alert" letter dated March 14, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect your inventory to determine if any inventory of product code 227305 lot with the number M1108086 that is incorrectly labeled; review the following label information and the attached examples of correct and incorrect labels; and complete and return the Business Reply Form via fax to: 1-508-828-3750. To return the product call 1-877-379-4871 for an RGA and replacement product and return to DePuy Mitek, Attn: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324. Contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-48.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
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