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Mitek VAPR Side Effect Electrode (integrated) recallZ-2301-2010 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Jun 7, 2010

Terminated All recalls posted in August 2010

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

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-2301-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 7, 2010
Posted by the FDA
Aug 27, 2010
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
112936 units
Product code
GEI
FDA submissions
K082643
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 description

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.

Code information (models, lots, serial numbers)

All lots of unexpired product

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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