Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD Recalled by Linvatec Corp. dba ConMed Linvatec Due to Linvatec Corporation dba ConMed Linvatec in Largo, FL...

Date: April 10, 2012
Company: Linvatec Corp. dba ConMed Linvatec
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Linvatec Corp. dba ConMed Linvatec directly.

Affected Products

"***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.

Quantity: 70 total

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 10 states: CA, GA, IL, LA, MS, NJ, NY, OH, PA, UT

Affected (10 states)Not affected

About Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report