FDAFDA · Food and drugs·Recall number Z-0384-2013
"***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.
Published November 28, 2012 · Recall initiated: April 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Distributor
- Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
- Lot
- S8585 (8.5MM Drill Bit), lot number 322287
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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