Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · United States · 2012-04-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0384-2013
Date of alert
2012-04-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Linvatec Corp. dba ConMed Linvatec
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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