Linvatec Corp. dba ConMed Linvatec: Medical Device Recall in 2012 - (Recall #: Z-0384-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 10, 2012

Date Posted: November 28, 2012

Recall Number: Z-0384-2013

Event ID: 63077

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.

Status: Terminated

Product Quantity: 70 total

Code Information:

S8585 (8.5MM Drill Bit), lot number 322287

Distribution Pattern:

Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.

Voluntary or Mandated:

Voluntary: Firm initiated