Z-0384-2013 Class II Terminated
FDA device recall Z-0384-2013 was initiated by Linvatec Corp. dba ConMed Linvatec on April 10, 2012 and is designated Class II. 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, lo… The recall status is terminated (terminated November 21, 2013). Affected quantity: 70 total.
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- April 10, 2012
- Termination Date
- November 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 total
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.
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.
Distribution Pattern
Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
Code Information
S8585 (8.5MM Drill Bit), lot number 322287