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DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with… recallZ-0133-2013 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Mar 12, 2012

Class II Terminated All recalls posted in October 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Error in labeling

What the company is doing

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

Recall details

Recall number
Z-0133-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 12, 2012
Posted by the FDA
Oct 24, 2012
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
376 units
Product code
GEI
FDA submissions
K082643
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.

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.

Code information (models, lots, serial numbers)

Lot Number: M1108086

Other devices under the same FDA submission

12 devices cleared under K082643 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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