CLASS II Device recall · Reported 31 Oct 2012 · FDA Enforcement Report

DePuy Mitek VAPR Hook Electrode Hook Electrode recalled

DePuy Mitek, Inc., a Johnson & Johnson is recalling DePuy Mitek VAPR Hook Electrode Hook Electrode with Integrated Handpiece, distributed nationwide in the US. The recall was initiated on 12 Mar 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: M1108086

Quantity recalled376 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0133-2013
FDA event ID: 63283
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 12 Mar 2012
FDA classified: 24 Oct 2012
Reported: 31 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

12 Mar 2012	Recall initiated by company
24 Oct 2012	Classified by FDA	+226 days
31 Oct 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama California Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kentucky Maryland Michigan Minnesota New Jersey New York Ohio Oregon Tennessee Texas Utah

Questions about this recall

Is DePuy Mitek VAPR Hook Electrode Hook Electrode with Integrated Handpiece recalled?

Yes. DePuy Mitek, Inc., a Johnson & Johnson recalled DePuy Mitek VAPR Hook Electrode Hook Electrode with Integrated Handpiece on 12 Mar 2012. The recall is Class II and its status is Terminated. Recall number Z-0133-2013.

Why was it 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

Which lots are affected?

Lot Number: M1108086

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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