ConMed Linvatec Recalls Sentinel Cannulated Drill Bits Due to Labeling Errors
ConMed Linvatec is recalling specific lots of Sentinel Cannulated Drill Bits because of incorrect labeling on the packages.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Linvatec Corporation dba ConMed Linvatec is recalling specific lots of Sentinel Cannulated Drill Bits. The affected products include the S8580, 8.0MM drill bit (lot numbers 322225 and 322226) and the S8585, 8.5MM drill bit (lot number 322287). These medical devices are used for drilling bone tunnels in ACL and PCL reconstruction.
The recall was initiated due to incorrect labeling on the packages. The source text does not specify the nature of the labeling error or report any injuries or illnesses associated with the use of these devices.
The affected units were distributed worldwide, including in the United States and internationally to Canada, Japan, and Romania. The source text does not provide specific instructions for consumers or healthcare providers regarding the next steps for the recalled items.
The recalled product
- 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.
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Hazard
- Affected units
- 70
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- S8585 (8.5MM Drill Bit)
- lot number 322287
Distribution
Part of a larger recall action
This product is one of 2 recalled by Linvatec Corp. dba ConMed Linvatec under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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