FDA Enforcement
Class II
Terminated
"***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.
Recall: Z-0383-2013
·
Reported November 28, 2012
Enforcement
- Recall Number
- Z-0383-2013
- Event ID
- 63077
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Linvatec Corp. dba ConMed Linvatec
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 28, 2012
- Initiation Date
- April 10, 2012
- Classification Date
- November 19, 2012
- Termination Date
- November 21, 2013
- Address
- 11311 Concept Blvd, N/A, Largo, FL, 33773-4908, United States
Description
"***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.
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 Info
S8580 (8.0MM Drill Bit), lot numbers 322225 and 322226
Distribution
Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
Quantity
70 total