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U.S. Department of Health and Human Services

Class 2 Device Recall ArthroKnife

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  Class 2 Device Recall ArthroKnife see related information
Date Initiated by Firm July 31, 2009
Date Posted October 21, 2009
Recall Status1 Terminated 3 on February 25, 2011
Recall Number Z-0067-2010
Recall Event ID 52808
Product Classification Knife, orthopedic - Product Code HST
Product Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO. 5.141.517.

The Arthro-Knife is a one piece disposable assembly comprised of a plastic handle with a retractable blade, sheathed blade. These knives are supplied sterile, single-use. Each knife assembly contains a color coded sliding retractor that coincides with a specific blade type. The blade can be extended and locked to a half extended position or fully extended position.
Code Information All product with the following Catalog Numbers:  70-0071-103 ANTHRO-KNIFE BANANA STR 6EA;  70-0078-103 ARTHRO-KNIFE 2 SIDE RND S 6 EA;  70-0071-113 ARTHRO-KNIFE BANANA LEFT 6 EA;  70-0074-103 ARTHRO KNIFE ROSETTE STR 6 EA;  70-0076-003 ARTHRO KNIFE CRESENT STR 6 EA;  70-0077-103 ARTHRO-KNIFE 2-SIDE POINT 6 EA;  70-0072-003 ARTHRO-KNIFE HOOK STR 6 EA;  70-0073-003 ARTHRO-KNIFE RETRO STR 6 EA;  70-0075-003 ARTHRO-KNIFE MINI MENISCU 6 EA.
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Sue Sutton-Jones
727-399-5334
Manufacturer Reason
for Recall		 ConMed has determined there is a possibility that the device may not fully retract once it is deployed.
FDA Determined
Cause 2		 Process control
Action ConvaMed Linvatec USA issued an "Urgent Medical Device Recall" notification via Fed Ex to all direct consignees of the affected product. Users were asked to inventory and return all affected product to the firm and to return a reply form by mail or fax. For further information, contact customer service at 1-800-237-0169 for US or your local ConMed Linvatec office for outside US or email at Custserv1@linvatec.com.
Quantity in Commerce Approximately 66,144 products.
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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