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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 63107
Product Type Devices
Status Ongoing
Recalling Firm Linvatec Corp. dba ConMed Linvatec
City Largo
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-07-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures. Catalog # 24k100 Lot #: 20853-000 20854-000 20855-000 21791-000 22172-000 22414-000 22513-000 22667-000 22724-000 22725-000 23606-000 23912 23912-000 23971-000 24177-000 24296-000 24348-000 24373-000 24476-000 24559-000 24671-000 24703-000 24905-000 25668-000 25794-000 25931-000 26025-000 26041-000 26294-000 26448-000 26486-000 27130-000 27255 27255-000 27322 27520 Class II ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents. 30064 units Z-2469-2012