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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Linvatec 2.9MM Full Radius Resector

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  Class 2 Device Recall ConMed Linvatec 2.9MM Full Radius Resector see related information
Date Initiated by Firm November 12, 2009
Date Posted February 10, 2012
Recall Status1 Terminated 3 on February 13, 2012
Recall Number Z-0987-2012
Recall Event ID 59092
Product Classification Blade, saw, general & plastic surgery, surgical - Product Code GFA
Product ***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***ConMed Linvatec Biomaterials, Ltd.Hermiankatu 6-8L 33720 Tampere, FINLAND.***Lot number # 95987.

Soft Tissue resection and removal.
Code Information Lot # 95987
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Roger Murphy
727-392-6464
Manufacturer Reason
for Recall		 ConMed Linvatec, Largo, FL recalled catalog number, C9944A, lot # 95987, 2.9MM Full Radius Resector Blade in November 2009 because there was a possibility that the device was assembled with an incorrect outer tube.
FDA Determined
Cause 2		 Employee error
Action A Linvatec Corporation dba ConMed Linvatec sales representative contacted the affected customers by telephone on November 12, 2009. The customers were also contacted by the Recall Coordinator. The product, problem, and action to be taken by the customers were discussed. Customers with the product in their inventory were instructed to return the product to the firm. Contact the firm at 727-399-5205 for questions regarding this recall.
Quantity in Commerce 30 Units
Distribution Product Distributed in the states of Georgia and New York.
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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