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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 Device Recall VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiecesee related information
Date Initiated by FirmMarch 12, 2012
Date PostedOctober 24, 2012
Recall Status1 Terminated 3 on June 05, 2015
Recall NumberZ-0133-2013
Recall Event ID 63283
510(K)NumberK082643 
Product Classification Electrosurgical, cutting; coagulation; accessories - Product Code GEI
ProductDePuy 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 MA 02767
For Additional Information ContactSandra 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		Error in labeling
ActionThe 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 Commerce376 units
DistributionNationwide 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
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