Z-0133-2013Class II

DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The...

Name: Z-0133-2013 DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2012-03-12
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2012-03-12 / Terminated / root cause: labeling and UDI

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of 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... on 2012-03-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0133-2013
Classification: Class II
Status: Terminated
Initiated: 2012-03-12
Posted: 2012-10-24
Terminated: 2015-06-05
Recalling firm: DePuy Mitek, Inc.
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot Number: M1108086

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0133-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0133-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24

Product code GEI

K082643Class II3.5 Mm Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 Mm Angled Side Effect Electrode with IntegrateDepuy Mitek, A Johnson & Johnson Company / cleared 2008-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)