***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.
FDA Recall Z-0987-2012 · Posted 2012-02-10
Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeGFA
Date Initiated2009-11-12
Date Terminated2012-02-13
Product Quantity30 Units
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Product Distributed in the states of Georgia and New York.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.