Recall Z-0384-2013— Linvatec Corp. dba ConMed Linvatec
Class II · Terminated
Class II FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2012-04-10, terminated 2013-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: "***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: 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..
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-10
- Terminated
- 2013-11-21
- Firm location
- Largo, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.