| Class 2 Device Recall ConMed Linvatec 2.9MM Full Radius Resector | |
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
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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
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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 |
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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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