FDA Medical Device Recalls (openFDA)
Linvatec Corp. dba ConMed Linvatec: "***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.
- Recall number
- Z-0384-2013
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Product
- "***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.
- Status
- Terminated
- Initiated
- 2012-04-10
- Posted
- 2012-11-19
- Terminated
- 2013-11-21
- Reason
- 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
- 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 Custserv@linvatec.com. For questions regarding this recall call 727-392-6464.
- Quantity
- 70 total
- Distribution
- Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
- Lot, serial or model codes
- S8585 (8.5MM Drill Bit), lot number 322287
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- Firm FEI
- 1017294
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28