Z-2301-2010

Mitek VAPR Side Effect Electrode (integrated)

Name: Z-2301-2010 Mitek VAPR Side Effect Electrode (integrated)
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2010-06-07
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2010-06-07 / Terminated / root cause: packaging

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short... on 2010-06-07. The reason FDA records is "Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2301-2010
Status: Terminated
Initiated: 2010-06-07
Posted: 2010-08-27
Terminated: 2012-07-12
Recalling firm: DePuy Mitek, Inc.
Product: Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm, Depuy Mitek, sent an "Urgent Voluntary Product Recall" letter dated June 7, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to not use any of the identified recalled products; to isolate all inventory of the affected product; complete the Business Reply Form, and return the affected products along with the form to Depuy Mitek; ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or fax completed form to 1-508-828-3750. Note the IMPORTANT PRODUCT INFORMATION: Any product that contains a round green sticker has been 100% inspected, meets specifications and is acceptable for use. Please Do Not Return any product that is labeled with the green dots because this product is not affected by the recall. If you have any questions or concerns with regard to this program, please contact your local Depuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682.
Quantity in commerce: 112936 units
Distribution: Worldwide distribution: USA and countries including Canada, Argentina, Australia, Bahrain, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhastan, Kuwait, Lebanon, Maylasia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Peru, Poland, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Portugal, Sweden, Switzerland, Syria, Thailand ,Turkey, UK, Ukraine, UAE, Venezuela, Vietnam, and Yemen.
Product codes and lots: All lots of unexpired product

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)