Z-0383-2013Class II

"SENTINELCannulated Drill BitS85808 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL...

Name: Z-0383-2013 "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2012-04-10
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2012-04-10 / Terminated / root cause: labeling and UDI

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of "***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... on 2012-04-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0383-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-10
Posted: 2012-11-19
Terminated: 2013-11-21
Recalling firm: Linvatec Corporation
Product: "***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.
Product code: HTW Bit, Drill
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: ConMed/Linvatec sent an Urgent Medical Device Recall Notificaiton letter via phone and FedEx on April 9, 2012 and again on May 11, 2012, to all affected customers. They also sent the same Notification on May 14, 2012, to international accounts. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete a reply formand fax it to 727-319-5701. Customers were also instructed to return all affected product to the firm. All returned product under this removal action will be identified, segregated and quarantined per firm procedures, etc. Customers with questions should contact Customers Service at [email protected]. For questions regarding this recall call 727-392-6464.
Quantity in commerce: 70 total
Distribution: Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
Product codes and lots: S8580 (8.0MM Drill Bit), lot numbers 322225 and 322226

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0383-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0383-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0384-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)