"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm — Class II medical device recall Z-0383-2013
Terminated recall by Linvatec Corp. dba ConMed Linvatec, reported 2012-11-28, distributed in CA, GA, IL, LA, MS, NJ, NY, OH…. Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill
| Recall number | Z-0383-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Linvatec Corp. dba ConMed Linvatec, Largo, FL, United States |
| Recall initiated | 2012-04-10 |
| Classified | 2012-11-19 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-11-21 |
| Distributed | CA, GA, IL, LA, MS, NJ, NY, OH, PA, UT |
| Countries outside the US | CA, JP, RO |
| Quantity | 70 total |
| Reason classes | labeling |
| Lot numbers | 322225, 322226 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0383-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.