DePuy Mitek, Inc., a Johnson & Johnson Co.: Mitek VAPR Angled Side Effect Electrode (integrated) Product Code: 227302 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.

Recall number

Z-2303-2010

Recalling firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Product

Mitek VAPR Angled Side Effect Electrode (integrated) Product Code: 227302 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.

Status

Terminated

Initiated

2010-06-07

Posted

2010-08-27

Terminated

2012-07-12

Reason

Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility

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

7576 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.

Lot, serial or model codes

All lots of unexpired product

510(k) numbers

not on file

PMA numbers

not on file

Product code

GEI

Firm FEI

1221934

Firm city

Raynham

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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