Device product
"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
Z-0383-2013
Product summary
- Event
- Event 63077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 total
- Official record key
device-enforcement:Z-0383-2013
Official wording
Reason: 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.
Code information: S8580 (8.0MM Drill Bit), lot numbers 322225 and 322226
Distribution pattern: Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
Derived failure modes
-
Labeling or packaging
incorrect labeling