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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
Recall Number Z-0384-2013
Classification Class II
Code Info S8585 (8.5MM Drill Bit), lot number 322287
Product Distributed Qty 70 total
Reason For Recall Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.

Event Detail

Event Id 63077
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 2012-04-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.